11.2 - Ingliskeelne Nimekiri

EUROPEAN PHARMACOPOEIA 11.
INDEX
To aid users the index includes a reference to the supplement in which the latest version of a text can be found.
For example : Amylmetacresol...............................................11.1‑4641
means the monograph Amylmetacresol can be found on page 4641 of Supplement 11.1.
Note that where no reference to a supplement is made, the text can be found in the principal volume.
English index ..................................................................... 4975 Latin index .............................................................................. 5011
General Notices (1) apply to all monographs and other texts 4973
EUROPEAN PHARMACOPOEIA 11.2 Index
1. General notices......................................................................... 3 2.2.65. Voltametric titration .................................................... 128

2.1. Apparatus ............................................................................. 17 2.2.66. Detection and measurement of radioactivity ........... 129
2.1.1. Droppers ........................................................................... 17 2.2.7. Optical rotation ................................................................ 31
2.1.2. Comparative table of porosity of sintered-glass filters.. 17 2.2.8. Viscosity ............................................................................ 32
2.1.3. Ultraviolet ray lamps for analytical purposes............... 17 2.2.9. Capillary viscometer method ......................................... 33
2.1.4. Sieves ................................................................................. 18 2.3. Identification...................................................................... 139
2.1.5. Tubes for comparative tests ............................................ 19 2.3.1. Identification reactions of ions and functional
2.1.6. Gas detector tubes............................................................ 19 groups ...................................................................................... 139
2.1.7. Balances for analytical purposes .................................... 20 2.3.2. Identification of fatty oils by thin-layer
2.2. Physical and physico-chemical methods.......................... 25 chromatography...................................................................... 142
2.2.1. Clarity and degree of opalescence of liquids ................ 25 2.3.3. Identification of phenothiazines by thin-layer
2.2.10. Viscosity - Rotating viscometer method ..................... 33 chromatography...................................................................... 143
2.2.11. Distillation range ........................................................... 36 2.3.4. Odour .............................................................................. 143
2.2.12. Boiling point................................................................... 37 2.4. Limit tests........................................................................... 147
2.2.13. Determination of water by distillation ........................ 37 2.4.1. Ammonium .................................................................... 147
2.2.14. Melting point - capillary method................................. 38 2.4.10. Lead in sugars............................................................... 152
2.2.15. Melting point - open capillary method ....................... 38 2.4.11. Phosphates .................................................................... 152
2.2.16. Melting point - instantaneous method........................ 38 2.4.12. Potassium ...................................................................... 152
2.2.17. Drop point ...................................................................... 39 2.4.13. Sulfates........................................................................... 152
2.2.18. Freezing point................................................................. 40 2.4.14. Sulfated ash ................................................................... 152
2.2.19. Amperometric titration................................................. 41 2.4.15. Nickel in polyols........................................................... 153
2.2.2. Degree of coloration of liquids....................................... 26 2.4.16. Total ash ........................................................................ 153
2.2.20. Potentiometric titration ................................................ 41 2.4.17. Aluminium ................................................................... 153
2.2.21. Fluorimetry..................................................................... 41 2.4.18. Free formaldehyde ....................................................... 153
2.2.22. Atomic emission spectrometry .................................... 42 2.4.19. Alkaline impurities in fatty oils.................................. 154
2.2.23. Atomic absorption spectrometry ................................. 43 2.4.2. Arsenic............................................................................. 147
2.2.24. Absorption spectrophotometry, infrared.................... 45 2.4.20. Determination of elemental impurities..................... 154
2.2.25. Absorption spectrophotometry, ultraviolet and 2.4.21. Foreign oils in fatty oils by thin-layer
visible ......................................................................................... 48 chromatography...................................................................... 157
2.2.26. Paper chromatography .................................................. 52 2.4.22. Composition of fatty acids by gas chromatography.. 157
2.2.27. Thin-layer chromatography............................. 11.1-4501 2.4.23. Sterols in fatty oils........................................................ 160
2.2.28. Gas chromatography......................................... 11.1-4502 2.4.24. Identification and control of residual solvents ......... 162
2.2.29. Liquid chromatography.................................... 11.1-4503 2.4.25. Ethylene oxide and dioxan.......................................... 167
2.2.3. Potentiometric determination of pH ............................. 29 2.4.26. N,N-Dimethylaniline ................................................... 168
2.2.30. Size-exclusion chromatography ...................... 11.1-4505 2.4.27. Heavy metals in herbal drugs and herbal drug
2.2.31. Electrophoresis ............................................................... 57 preparations ............................................................................ 168
2.2.32. Loss on drying................................................................ 63 2.4.28. 2-Ethylhexanoic acid ................................................... 170
2.2.33. Nuclear magnetic resonance spectrometry ................ 63 2.4.29. Composition of fatty acids in oils rich in omega-3
2.2.34. Thermal analysis ............................................................ 66 acids.......................................................................................... 171
2.2.35. Osmolality....................................................................... 69 2.4.3. Calcium ........................................................................... 148
2.2.36. Potentiometric determination of ionic 2.4.30. Ethylene glycol and diethylene glycol in ethoxylated
concentration using ion-selective electrodes ........................ 69 substances................................................................................ 173
2.2.37. X-ray fluorescence spectrometry ................................. 71 2.4.31. Nickel in hydrogenated vegetable oils ....................... 173
2.2.38. Conductivity ................................................................... 72 2.4.32. Total cholesterol in oils rich in omega-3 acids ......... 174
2.2.39. Molecular mass distribution in dextrans .................... 74 2.4.33. Tetrabutylammonium in radiopharmaceutical
2.2.4. Approximate pH of solutions ......................................... 30 preparations ............................................................................ 175
2.2.40. Near-infrared spectroscopy .......................................... 76 2.4.4. Chlorides......................................................................... 148
2.2.41. Circular dichroism......................................................... 81 2.4.5. Fluorides.......................................................................... 148
2.2.42. Density of solids............................................................. 82 2.4.6. Magnesium ..................................................................... 148
2.2.43. Mass spectrometry......................................................... 83 2.4.7. Magnesium and alkaline-earth metals ........................ 149
2.2.44. Total organic carbon in water for pharmaceutical 2.4.8. Heavy metals................................................................... 149
use............................................................................................... 85 2.4.9. Iron .................................................................................. 152
2.2.45. Supercritical fluid chromatography ................ 11.1-4505 2,4-Dichlorobenzyl alcohol ................................................... 2517
2.2.46. Chromatographic separation techniques .................... 86 2.5. Assays ................................................................................. 179
2.2.47. Capillary electrophoresis............................................... 96 2.5.1. Acid value........................................................................ 179
2.2.48. Raman spectroscopy.................................................... 101 2.5.10. Oxygen-flask method .................................................. 182
2.2.49. Falling ball and automatic rolling ball viscometer 2.5.11. Complexometric titrations.......................................... 182
methods ................................................................................... 104 2.5.12. Water : semi-micro determination ............................. 183
2.2.5. Relative density................................................................. 31 2.5.13. Aluminium in adsorbed vaccines .............................. 183
2.2.54. Isoelectric focusing ...................................................... 104 2.5.14. Calcium in adsorbed vaccines .................................... 184
2.2.55. Peptide mapping .......................................................... 106 2.5.15. Phenol in immunosera and vaccines......................... 184
2.2.56. Amino acid analysis..................................................... 109 2.5.16. Protein in polysaccharide vaccines ............................ 184
2.2.57. Inductively coupled plasma-atomic emission 2.5.17. Nucleic acids in polysaccharide vaccines .................. 184
spectrometry ........................................................................... 116 2.5.18. Phosphorus in polysaccharide vaccines .................... 184
2.2.58. Inductively coupled plasma-mass spectrometry...... 117 2.5.19. O-Acetyl in polysaccharide vaccines ......................... 185
2.2.59. Glycan analysis of glycoproteins ................................ 119 2.5.2. Ester value....................................................................... 179
2.2.6. Refractive index................................................................ 31 2.5.20. Hexosamines in polysaccharide vaccines.................. 185
2.2.61. Characterisation of crystalline solids by 2.5.21. Methylpentoses in polysaccharide vaccines.............. 185
microcalorimetry and solution calorimetry........................ 124 2.5.22. Uronic acids in polysaccharide vaccines ................... 186
2.2.63. Direct amperometric and pulsed electrochemical 2.5.23. Sialic acid in polysaccharide vaccines ....................... 186
detection .................................................................................. 126 2.5.24. Carbon dioxide in gases .............................................. 186
2.2.64. Peptide identification by nuclear magnetic resonance 2.5.25. Carbon monoxide in gases ......................................... 187
spectrometry ........................................................................... 128 2.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 188
Index EUROPEAN PHARMACOPOEIA 11.2
2.5.27. Oxygen in gases............................................................ 188 2.6.8. Pyrogens.......................................................................... 215

2.5.28. Water in gases............................................................... 188 2.7. Biological assays ................................................................ 277
2.5.29. Sulfur dioxide ............................................................... 189 2.7.1. Immunochemical methods........................................... 277
2.5.3. Hydroxyl value ............................................................... 179 2.7.10. Assay of human coagulation factor VII .................... 296
2.5.30. Oxidising substances ................................................... 189 2.7.11. Assay of human coagulation factor IX ...................... 297
2.5.31. Ribose in polysaccharide vaccines ............................. 190 2.7.12. Assay of heparin in coagulation factors .................... 297
2.5.32. Water : micro determination....................................... 190 2.7.13. Assay of human anti-D immunoglobulin ................. 298
2.5.33. Total protein ................................................................. 191 2.7.14. Assay of hepatitis A vaccine........................................ 300
2.5.34. Acetic acid in synthetic peptides................................ 194 2.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 300
2.5.35. Nitrous oxide in gases ................................................. 194 2.7.16. Assay of pertussis vaccine (acellular) ........................ 301
2.5.36. Anisidine value............................................................. 194 2.7.17. Assay of human antithrombin III .............................. 303
2.5.37. Methyl, ethyl and isopropyl methanesulfonate in 2.7.18. Assay of human coagulation factor II ....................... 303
methanesulfonic acid ............................................................. 194 2.7.19. Assay of human coagulation factor X........................ 304
2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active 2.7.2. Microbiological assay of antibiotics............................. 278
substances................................................................................ 195 2.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 304
2.5.39. Methanesulfonyl chloride in methanesulfonic 2.7.21. Assay of human von Willebrand factor..................... 305
acid ........................................................................................... 196 2.7.22. Assay of human coagulation factor XI ...................... 307
2.5.4. Iodine value .................................................................... 179 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic
2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active products ................................................................................... 307
substances................................................................................ 197 2.7.24. Flow cytometry ............................................................ 308
2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active 2.7.25. Assay of human plasmin inhibitor............................. 310
substances................................................................................ 198 2.7.26. Cell-based assays for potency determination of
2.5.42. N-Nitrosamines in active substances......................... 199 TNF-alpha antagonists................................................ 11.1-4513
2.5.5. Peroxide value................................................................. 180 2.7.27. Flocculation value (Lf) of diphtheria and tetanus toxins
2.5.6. Saponification value....................................................... 181 and toxoids (Ramon assay) ................................................... 310
2.5.7. Unsaponifiable matter ................................................... 181 2.7.28. Colony-forming cell assay for human
2.5.8. Determination of primary aromatic amino- haematopoietic progenitor cells............................................ 311
nitrogen.................................................................................... 181 2.7.29. Nucleated cell count and viability.............................. 312
2.5.9. Determination of nitrogen by sulfuric acid 2.7.30. Assay of human protein C .......................................... 314
digestion .................................................................................. 182 2.7.31. Assay of human protein S ........................................... 315
2.6. Biological tests ................................................................... 207 2.7.32. Assay of human α-1-proteinase inhibitor ................. 315
2.6.1. Sterility ............................................................................ 207 2.7.34. Assay of human C1-esterase inhibitor ...................... 316
2.6.10. Histamine...................................................................... 216 2.7.35. Immunonephelometry for vaccine component
2.6.11. Depressor substances................................................... 217 assay ......................................................................................... 316
2.6.12. Microbiological examination of non-sterile products : 2.7.36. Assay of Bet v 1 allergen.............................................. 317
microbial enumeration tests.................................................. 217 2.7.4. Assay of human coagulation factor VIII ..................... 284
2.6.13. Microbiological examination of non-sterile products : 2.7.5. Assay of heparin............................................................. 285
test for specified micro-organisms ....................................... 221 2.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 285
2.6.14. Bacterial endotoxins .................................................... 226 2.7.7. Assay of pertussis vaccine (whole cell)........................ 290
2.6.15. Prekallikrein activator ................................................. 230 2.7.8. Assay of tetanus vaccine (adsorbed)............................ 291
2.6.16. Tests for extraneous agents in viral vaccines for human 2.7.9. Test for Fc function of immunoglobulin..................... 295
use............................................................................................. 230 2.8. Methods in pharmacognosy ............................................ 321
2.6.17. Test for anticomplementary activity of 2.8.1. Ash insoluble in hydrochloric acid .............................. 321
immunoglobulin.......................................................... 11.1-4509 2.8.10. Solubility in alcohol of essential oils.......................... 323
2.6.18. Test for neurovirulence of live virus vaccines .......... 234 2.8.11. Assay of 1,8-cineole in essential oils.......................... 323
2.6.2. Mycobacteria .................................................................. 210 2.8.12. Essential oils in herbal drugs...................................... 323
2.6.20. Anti-A and anti-B haemagglutinins .......................... 235 2.8.13. Pesticide residues ......................................................... 324
2.6.21. Nucleic acid amplification techniques....................... 236 2.8.14. Tannins in herbal drugs .............................................. 326
2.6.22. Activated coagulation factors ..................................... 240 2.8.15. Bitterness value............................................................. 326
2.6.26. Test for anti-D antibodies in human immunoglobu- 2.8.16. Dry residue of extracts ................................................ 327
lin.............................................................................................. 240 2.8.17. Loss on drying of extracts........................................... 327
2.6.27. Microbiological examination of cell-based 2.8.18. Determination of aflatoxin B1 in herbal drugs ......... 327
preparations ............................................................................ 241 2.8.2. Foreign matter ..................................................... 11.1-4519
2.6.30. Monocyte-activation test............................................. 244 2.8.20. Herbal drugs : sampling and sample preparation .... 329
2.6.31. Microbiological examination of herbal medicinal 2.8.21. Test for aristolochic acids in herbal drugs ................ 330
products for oral use and extracts used in their 2.8.22. Determination of ochratoxin A in herbal drugs ...... 332
preparation .............................................................................. 249 2.8.23. Microscopic examination of herbal drugs ................ 333
2.6.32. Test for bacterial endotoxins using recombinant 2.8.24. Foam index ................................................................... 333
factor C .................................................................................... 252 2.8.25. High-performance thin-layer chromatography of
2.6.33. Residual pertussis toxin............................................... 254 herbal drugs and herbal drug preparations ........................ 334
2.6.34. Host-cell protein assays............................................... 256 2.8.26. Contaminant pyrrolizidine alkaloids......................... 335
2.6.35. Quantification and characterisation of residual 2.8.3. Stomata and stomatal index.......................................... 321
host-cell DNA ......................................................................... 260 2.8.4. Swelling index................................................................. 322
2.6.36. Microbiological examination of live biotherapeutic 2.8.5. Water in essential oils .................................................... 322
products : tests for enumeration of microbial 2.8.6. Foreign esters in essential oils ...................................... 322
contaminants........................................................................... 262 2.8.7. Fatty oils and resinified essential oils in essential
2.6.37. Principles for the detection of extraneous viruses in oils ............................................................................................ 322
immunological veterinary medicinal products using culture 2.8.8. Odour and taste of essential oils .................................. 322
methods ................................................................................... 267 2.8.9. Residue on evaporation of essential oils ..................... 322
2.6.38. Microbiological examination of live biotherapeutic 2.9. Pharmaceutical technical procedures ............................. 345
products : tests for specified micro-organisms.................... 267 2.9.1. Disintegration of tablets and capsules......................... 345
2.6.39. Microbiological examination of human tissues ....... 271 2.9.10. Ethanol content ............................................................ 362
2.6.7. Mycoplasmas .................................................................. 210 2.9.11. Test for methanol and 2-propanol ............................. 364
4976 See the information section on general monographs (cover pages)

2.9.12. Sieve test........................................................................ 366 3.1.8. Silicone oil used as a lubricant ..................................... 462
2.9.14. Specific surface area by air permeability................... 366 3.1.9. Silicone elastomer for closures and tubing ................. 462
2.9.16. Flowability..................................................................... 368 3.2. Containers.......................................................................... 479
2.9.17. Test for extractable volume of parenteral 3.2.1. Glass containers for pharmaceutical use..................... 479
preparations ............................................................................ 369 3.2.2. Plastic containers and closures for pharmaceutical
2.9.18. Preparations for inhalation : aerodynamic assessment use............................................................................................. 485
of fine particles........................................................................ 369 3.2.2.1. Plastic containers for aqueous solutions for
2.9.19. Particulate contamination : sub-visible particles...... 382 infusion .................................................................................... 486
2.9.2. Disintegration test for solid rectal and vaginal dosage 3.2.9. Rubber closures for containers for aqueous
forms ........................................................................................ 347 parenteral preparations, for powders and for
2.9.20. Particulate contamination : visible particles ............. 385 freeze-dried powders................................................... 11.1-4529
2.9.22. Softening time determination of lipophilic 3.3. Containers for human blood and blood components, and
suppositories ........................................................................... 385 materials used in their manufacture ; transfusion sets and
2.9.23. Gas pycnometric density of solids ............................. 386 materials used in their manufacture ; syringes.................... 491
2.9.25. Dissolution test for medicated chewing gums ......... 387 3.3.1. Materials for containers for human blood and blood
2.9.26. Specific surface area by gas adsorption ..................... 392 components ............................................................................. 491
2.9.27. Uniformity and accuracy of delivered doses from 3.3.2. Materials based on plasticised poly(vinyl chloride) for
multidose containers .............................................................. 395 containers for human blood and blood components......... 491
2.9.29. Intrinsic dissolution..................................................... 395 3.3.3. Materials based on plasticised poly(vinyl chloride) for
2.9.3. Dissolution test for solid dosage forms ....................... 348 tubing used in sets for the transfusion of blood and blood
2.9.31. Particle size analysis by laser light diffraction.......... 396 components ............................................................................. 494
2.9.32. Porosity and pore-size distribution of solids by 3.3.4. Sterile plastic containers for human blood and blood
mercury porosimetry ............................................................. 400 components ............................................................................. 497
2.9.33. Characterisation of crystalline and partially crystalline 3.3.5. Empty sterile containers of plasticised poly(vinyl
solids by X-ray powder diffraction (XRPD)........................ 402 chloride) for human blood and blood components........... 499
2.9.34. Bulk density and tapped density of powders............ 407 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for
2.9.35. Powder fineness............................................................ 410 human blood containing anticoagulant solution ............... 500
2.9.36. Powder flow .................................................................. 410 3.3.7. Sets for the transfusion of blood and blood
2.9.37. Optical microscopy...................................................... 413 components ............................................................................. 501
2.9.38. Particle-size distribution estimation by analytical 3.3.8. Sterile single-use plastic syringes ................................. 503
sieving ........................................................................... 11.1-4523 3-O-Desacyl-4′-monophosphoryl lipid A............................ 2481
2.9.39. Water-solid interactions : determination of 4. Reagents................................................................................. 507
sorption-desorption isotherms and of water activity......... 417 4.1. Reagents, standard solutions, buffer solutions .............. 507
2.9.4. Dissolution test for patches........................................... 355 4.1.1. Reagents .......................................................................... 507
2.9.40. Uniformity of dosage units ......................................... 421 4.1.1. Reagents ............................................................... 11.1-4535
2.9.41. Friability of granules and spheroids .......................... 423 4.1.1. Reagents ............................................................... 11.2-4839
2.9.42. Dissolution test for lipophilic solid dosage forms ... 424 4.1.2. Standard solutions for limit tests ................................. 628
2.9.43. Apparent dissolution ................................................... 426 4.1.3. Buffer solutions .............................................................. 632
2.9.44. Preparations for nebulisation : characterisation ....... 427 4.2. Volumetric analysis........................................................... 638
2.9.45. Wettability of porous solids including powders....... 429 4.2.1. Primary standards for volumetric solutions............... 638
2.9.47. Demonstration of uniformity of dosage units using 4.2.2. Volumetric solutions...................................................... 639
large sample sizes.................................................................... 432 4-Aminobenzoic acid ............................................................. 1940
2.9.49. Powder flow properties by shear cell methods......... 434 5.1. General texts on microbiology ........................................ 649
2.9.5. Uniformity of mass of single-dose preparations ..... 11.1- 5.10. Control of impurities in substances for pharmaceutical
4523 use............................................................................................. 799
2.9.52. Scanning electron microscopy ................................... 437 5.11. Characters section in monographs ............................... 805
2.9.53. Particulate contamination : sub-visible particles in 5.1.1. Methods of preparation of sterile products ................ 649
non-injectable liquid preparations ....................................... 441 5.1.10. Guidelines for using the test for bacterial
2.9.6. Uniformity of content of single-dose preparations.... 358 endotoxins ............................................................................... 669
2.9.7. Friability of uncoated tablets ........................................ 359 5.1.11. Determination of bactericidal, fungicidal or yeasticidal
2.9.8. Resistance to crushing of tablets .................................. 360 activity of antiseptic medicinal products............................. 673
2.9.9. Measurement of consistency by penetrometry .......... 360 5.1.12. Depyrogenation of items used in the production of
3.1. Materials used for the manufacture of containers ........ 449 parenteral preparations.......................................................... 674
3.1.10. Materials based on non-plasticised poly(vinyl chloride) 5.1.2. Biological indicators and related microbial preparations
for containers for non-injectable, aqueous solutions......... 463 used in the manufacture of sterile products........................ 652
3.1.11. Materials based on non-plasticised poly(vinyl 5.12. Reference standards ........................................................ 809
chloride) for containers for solid dosage forms for oral 5.1.3. Efficacy of antimicrobial preservation ........................ 655
administration......................................................................... 465 5.14. Gene transfer medicinal products for human use ...... 815
3.1.13. Plastic additives ............................................................ 467 5.1.4. Microbiological quality of non-sterile pharmaceutical
3.1.14. Materials based on plasticised poly(vinyl chloride) preparations and substances for pharmaceutical use......... 657
for containers for aqueous solutions for intravenous 5.1.5. Application of the F concepts to heat sterilisation
infusion .................................................................................... 471 processes .................................................................................. 658
3.1.15. Polyethylene terephthalate for containers for 5.15. Functionality-related characteristics of excipients...... 829
preparations not for parenteral use ...................................... 474 5.1.6. Alternative methods for control of microbiological
3.1.3. Polyolefins ....................................................................... 449 quality ...................................................................................... 658
3.1.4. Polyethylene without additives for containers for 5.16. Crystallinity ..................................................................... 833
parenteral preparations and for ophthalmic preparations.. 452 5.17. Recommendations on methods for dosage forms
3.1.5. Polyethylene with additives for containers for parenteral testing....................................................................................... 837
preparations and for ophthalmic preparations ................... 453 5.1.7. Viral safety ...................................................................... 667
3.1.6. Polypropylene for containers and closures for parenteral 5.17.1. Recommendations on dissolution testing................. 837
preparations and ophthalmic preparations ......................... 457 5.17.2. Recommendations on testing of particulate
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing contamination : visible particles............................................ 839
for total parenteral nutrition preparations .......................... 460
5.18. Methods of pretreatment for preparing traditional Aceclofenac.............................................................................. 1861

Chinese drugs : general information .................................... 843 Acemetacin .............................................................................. 1862
5.1.8. Microbiological quality of herbal medicinal products for Acesulfame potassium............................................................ 1864
oral use and extracts used in their preparation .................. 668 Acetate trihydrate, sodium .................................................... 3969
5.19. Extemporaneous preparation of radiopharmaceuti- Acetazolamide......................................................................... 1865
cals ............................................................................................ 849 Acetic acid, glacial .................................................................. 1866
5.1.9. Guidelines for using the test for sterility..................... 669 Acetic acid in synthetic peptides (2.5.34.) ............................. 194
5.2. General texts on biological products .............................. 679 Acetone .................................................................................... 1867
5.20. Elemental impurities ...................................................... 857 Acetylcholine chloride ........................................................... 1868
5.21. Chemometric methods applied to analytical Acetylcysteine.......................................................................... 1869
data ................................................................................ 11.1-4545 β-Acetyldigoxin....................................................................... 1870
5.2.1. Terminology used in monographs on biological Acetylene intermix (1 per cent) in nitrogen........................ 1873
products ................................................................................... 679 Acetylsalicylic acid ................................................................. 1874
5.2.11. Carrier proteins for the production of conjugated Acetyltryptophan, N- ............................................................. 1875
polysaccharide vaccines for human use............................... 711 Acetyltyrosine, N-................................................................... 1877
5.2.12. Raw materials of biological origin for the production Achyranthes bidentata root ................................................... 1361
of cell-based and gene therapy medicinal products ........... 712 Aciclovir................................................................................... 1878
5.2.13. Healthy chicken flocks for the production of inactivated Acid value (2.5.1.)..................................................................... 179
vaccines for veterinary use .................................................... 715 Acidum picrinicum for homoeopathic preparations ......... 1807
5.2.14. Substitution of in vivo method(s) by in vitro method(s) Acidum succinicum for homoeopathic preparations ........ 1808
for the quality control of vaccines ........................................ 716 Acitretin ................................................................................... 1880
5.2.2. Chicken flocks free from specified pathogens for the Actinobacillosis vaccine (inactivated), porcine .................. 1202
production and quality control of vaccines.............. 11.1-4539 Activated charcoal .................................................................. 2282
5.22. Names of herbal drugs used in traditional Chinese Activated coagulation factors (2.6.22.)................................... 240
medicine ....................................................................... 11.1-4573 Active substances - N-nitrosamines in (2.5.42.) ................... 199
5.2.3. Cell substrates for the production of vaccines for human Adapalene ................................................................................ 1882
use............................................................................................. 682 Additives, plastic (3.1.13.) ....................................................... 467
5.23. Monographs on herbal drug extracts (information Adenine.................................................................................... 1883
chapter) .................................................................................... 885 Adenosine ................................................................................ 1884
5.2.4. Cell cultures for the production of vaccines for Adenovirus vaccine (inactivated), canine............................ 1143
veterinary use.......................................................................... 686 Adenovirus vaccine (live), canine......................................... 1144
5.24. Chemical imaging ........................................................... 889 Adipic acid............................................................................... 1885
5.2.5. Management of extraneous agents in immunological Adonis vernalis for homoeopathic preparations ................ 1808
veterinary medicinal products .............................................. 688 Adrenaline ............................................................................... 1886
5.25. Process analytical technology........................................ 897 Adrenaline tartrate ................................................................. 1887
5.2.6. Evaluation of safety of veterinary vaccines and Adsorption, gas, specific surface area by (2.9.26.)................ 392
immunosera ........................................................................... 695 Aerodynamic assessment of fine particles in preparations for
5.26. Implementation of pharmacopoeial procedures ......... 903 inhalation (2.9.18.) ................................................................. 369
5.2.7. Evaluation of efficacy of veterinary vaccines and Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 327
immunosera ............................................................................ 697 Agar .......................................................................................... 1362
5.2.8. Minimising the risk of transmitting animal spongiform Agaricus phalloides for homoeopathic preparations ......... 1809
encephalopathy agents via human and veterinary medicinal Agnus castus fruit ................................................................... 1363
products ................................................................................... 698 Agnus castus fruit dry extract ............................................... 1364
5.28. Multivariate statistical process control.............. 11.1-4579 Agrimony................................................................................. 1365
5.2.9. Evaluation of safety of each batch of immunosera for Air, medicinal ......................................................................... 1889
veterinary use.......................................................................... 710 Air, synthetic medicinal......................................................... 1891
5.3. Statistical analysis of results of biological assays and Akebia stem ............................................................................. 1366
tests........................................................................................... 721 Alanine..................................................................................... 1892
5.30. Monographs on essential oils (information chapter).. 915 Albendazole............................................................................. 1893
5.4. Residual solvents ............................................................... 753 Albumin solution, human ..................................................... 2971
5.5. Alcoholimetric tables........................................................ 763 Albuterol .................................................................................. 3933
5.6. Assay of interferons .......................................................... 777 Albuterol sulfate...................................................................... 3936
5.7. Table of physical characteristics of radionuclides Alchemilla................................................................................ 1368
mentioned in the European Pharmacopoeia ...................... 781 Alcoholimetric tables (5.5.) ..................................................... 763
5.8. Pharmacopoeial harmonisation ...................................... 791 Alcuronium chloride.............................................................. 1894
5.9. Polymorphism ................................................................... 795 Alendronate trihydrate, sodium ........................................... 3969
Alexandrian senna pods ........................................................ 1725
A Alfacalcidol.............................................................................. 1896
Abacavir sulfate....................................................................... 1853 Alfadex ..................................................................................... 1897
Abbreviations and symbols (1.) .................................................. 3 Alfentanil hydrochloride hydrate ......................................... 1898
Abelmoschi corolla ................................................................. 1357 Alfuzosin hydrochloride ........................................................ 1900
Absorption spectrophotometry, infrared (2.2.24.)................. 45 Alginate, sodium..................................................................... 3971
Absorption spectrophotometry, ultraviolet and visible Alginic acid.............................................................................. 1901
(2.2.25.) ...................................................................................... 48 Alimemazine hemitartrate..................................................... 1902
Acacia ....................................................................................... 1358 Alkaline impurities in fatty oils (2.4.19.) ............................... 154
Acacia, dried dispersion......................................................... 1854 Alkaline-earth metals and magnesium (2.4.7.)..................... 149
Acamprosate calcium ............................................................. 1856 Alkaloids, contaminant pyrrolizidine (2.8.26.) ..................... 335
Acanthopanax bark ................................................................ 1360 Allantoin .................................................................................. 1903
Acarbose .................................................................................. 1857 Allergen products ..................................................................... 919
Accuracy and uniformity of delivered doses from multidose Allergen products, animal epithelia and outgrowths for... 1973
containers (2.9.27.) ................................................................. 395 Allergen products, Hymenoptera venoms for..................... 3048
Acebutolol hydrochloride ...................................................... 1859 Allergen products, mites for.................................................. 3427
Allergen products, moulds for .............................................. 3448

Allergen products, pollens for............................................... 3743 Ampicillin ................................................................................ 1963

Allium sativum for homoeopathic preparations ................ 1811 Ampicillin sodium.................................................................. 1965
Allopurinol .............................................................................. 1904 Ampicillin trihydrate.............................................................. 1967
all-rac-Phytomenadione ........................................................ 3712 Amprolium hydrochloride for veterinary use..................... 1969
all-rac-α-Tocopherol............................................................... 4236 Amylmetacresol ............................................................. 11.1-4641
all-rac-α-Tocopheryl acetate.................................................. 4239 Anacardium for homoeopathic preparations...................... 1813
Almagate .................................................................................. 1906 Anaemia vaccine (live), chicken, infectious ............... 11.1-4606
Almond oil, refined ................................................................ 1907 Analysis, thermal (2.2.34.)......................................................... 66
Almond oil, virgin .................................................................. 1908 Analytical sieving, particle-size distribution estimation by
Almotriptan malate ................................................................ 1908 (2.9.38.) ......................................................................... 11.1-4523
Aloes, Barbados ...................................................................... 1369 Anamirta cocculus for homoeopathic preparations .......... 1821
Aloes, Cape.............................................................................. 1370 Anastrozole.............................................................................. 1972
Aloes dry extract, standardised............................................. 1371 Andrographis herb ................................................................. 1373
Alovudine (18F) injection ....................................................... 1245 Anemarrhena asphodeloides rhizome ................................. 1375
Alphacyclodextrin .................................................................. 1897 Angelica archangelica root .................................................... 1377
Alprazolam .............................................................................. 1910 Angelica dahurica root........................................................... 1378
Alprenolol hydrochloride ...................................................... 1911 Angelica pubescens root ........................................................ 1380
Alprostadil ............................................................................... 1913 Angelica sinensis root ............................................................ 1382
Alteplase for injection ............................................................ 1915 Animal anti-T lymphocyte immunoglobulin for human
Alternative methods for control of microbiological quality use........................................................................................... 1978
(5.1.6.) ...................................................................................... 658 Animal epithelia and outgrowths for allergen products.... 1973
Altizide..................................................................................... 1918 Animal immunosera for human use ...................................... 929
Alum......................................................................................... 1919 Animal spongiform encephalopathies, products with risk of
Aluminium (2.4.17.)................................................................. 153 transmitting agents of ............................................................ 942
Aluminium chloride hexahydrate......................................... 1920 Animal spongiform encephalopathy agents, minimising the
Aluminium hydroxide, hydrated, for adsorption ............... 1920 risk of transmitting via human and veterinary medicinal
Aluminium in adsorbed vaccines (2.5.13.)............................ 183 products (5.2.8.)...................................................................... 698
Aluminium magnesium silicate ............................................ 1921 Anise oil ................................................................................... 1383
Aluminium oxide, hydrated .................................................. 1923 Aniseed .................................................................................... 1385
Aluminium phosphate gel ..................................................... 1924 Anisidine value (2.5.36.) .......................................................... 194
Aluminium phosphate, hydrated.......................................... 1924 Antazoline hydrochloride...................................................... 1974
Aluminium sodium silicate ................................................... 1925 Anthrax spore vaccine (live) for veterinary use.................. 1119
Aluminium stearate................................................................ 1926 Anthrax vaccine for human use (adsorbed, prepared from
Aluminium sulfate.................................................................. 1927 culture filtrates)..................................................................... 1013
Alverine citrate........................................................................ 1928 Anti-A and anti-B haemagglutinins (2.6.20.)........................ 235
Amantadine hydrochloride ................................................... 1929 Antibiotics, microbiological assay of (2.7.2.) ........................ 278
Ambroxol hydrochloride ....................................................... 1930 Antibodies (anti-D) in human immunoglobulin, test for
Amfetamine sulfate ................................................................ 1931 (2.6.26.) .................................................................................... 240
Amidotrizoate, sodium .......................................................... 3971 Antibodies for human use, monoclonal ..................... 11.2-4843
Amidotrizoic acid dihydrate ................................................. 1932 Anticoagulant and preservative solutions for human blood
Amikacin ................................................................................. 1934 ................................................................................................ 1975
Amikacin sulfate ..................................................................... 1936 Anticomplementary activity of immunoglobulin
Amiloride hydrochloride dihydrate ..................................... 1939 (2.6.17.) ......................................................................... 11.1-4509
Amino acid analysis (2.2.56.) .................................................. 109 Anti-D antibodies in human immunoglobulin, test for
Aminobenzoic acid, 4- ........................................................... 1940 (2.6.26.) .................................................................................... 240
Aminocaproic acid ................................................................. 1941 Anti-D immunoglobulin for intravenous administration,
Aminophylline ............................................................... 11.1-4756 human .................................................................................... 2974
Aminophylline hydrate ................................................. 11.1-4757 Anti-D immunoglobulin, human ......................................... 2973
Aminosalicylate dihydrate, sodium...................................... 3972 Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 298
Amiodarone hydrochloride................................................... 1942 Antimicrobial preservation, efficacy of (5.1.3.) .................... 655
Amisulpride............................................................................. 1944 Antiseptic medicinal products, determination of bactericidal,
Amitriptyline hydrochloride ................................................. 1945 fungicidal or yeasticidal activity of (5.1.11.) ....................... 673
Amlodipine besilate................................................................ 1947 Antiserum, European viper venom ...................................... 1238
Ammonia (13N) injection....................................................... 1247 Anti-T lymphocyte immunoglobulin for human use,
Ammonia solution, concentrated ......................................... 1948 animal .................................................................................... 1978
Ammonio methacrylate copolymer (type A)...................... 1949 Antithrombin III concentrate, human ................................. 2974
Ammonio methacrylate copolymer (type B) ...................... 1950 Antithrombin III, human, assay of (2.7.17.) ......................... 303
Ammonium (2.4.1.).................................................................. 147 Apis for homoeopathic preparations.................................... 1814
Ammonium bromide ............................................................. 1951 Apomorphine hydrochloride hemihydrate ......................... 1981
Ammonium carbonicum for homoeopathic prepara- Apparatus (2.1.) .......................................................................... 17
tions........................................................................................ 1812 Apparent dissolution (2.9.43.)................................................. 426
Ammonium chloride.............................................................. 1952 Application of the F concepts to heat sterilisation processes
Ammonium glycyrrhizate ..................................................... 1953 (5.1.5.) ...................................................................................... 658
Ammonium hydrogen carbonate ......................................... 1954 Approximate pH of solutions (2.2.4.)....................................... 30
Amomum fruit........................................................................ 1372 Aprepitant................................................................................ 1982
Amomum fruit, round ........................................................... 1701 Apricot seed, bitter ................................................................. 1417
Amorolfine hydrochloride..................................................... 1954 Aprotinin ................................................................................. 1984
Amoxicillin sodium................................................................ 1956 Aprotinin concentrated solution .......................................... 1986
Amoxicillin trihydrate............................................................ 1958 Arachis oil, hydrogenated...................................................... 1989
Amperometric detection, direct, and pulsed electrochemical Arachis oil, refined ................................................................. 1989
detection (2.2.63.)................................................................... 126 Arginine ................................................................................... 1990
Amperometric titration (2.2.19.) .............................................. 41 Arginine aspartate .................................................................. 1991
Amphotericin B ...................................................................... 1961 Arginine hydrochloride ......................................................... 1992
Argon ....................................................................................... 1993 Automatic rolling ball and falling ball viscometer methods
Aripiprazole............................................................................. 1994 (2.2.49.) .................................................................................... 104
Aristolochic acids in herbal drugs, test for (2.8.21) ............. 330 Avian infectious bronchitis vaccine (inactivated)............... 1123
Arnica flower.................................................................. 11.2-4853 Avian infectious bronchitis vaccine (live)................... 11.1-4597
Arnica tincture........................................................................ 1389 Avian infectious bursal disease vaccine (inactivated) ........ 1126
Arsenic (2.4.2.).......................................................................... 147 Avian infectious bursal disease vaccine (live) ............ 11.1-4598
Arsenicum album for homoeopathic preparations ............ 1815 Avian infectious encephalomyelitis vaccine (live) ..... 11.1-4600
Arsenious trioxide for homoeopathic preparations ........... 1815 Avian infectious laryngotracheitis vaccine (live)....... 11.1-4601
Articaine hydrochloride......................................................... 1996 Avian paramyxovirus 1 (Newcastle disease) vaccine
Artichoke leaf .......................................................................... 1390 (inactivated) .......................................................................... 1197
Artichoke leaf dry extract...................................................... 1391 Avian paramyxovirus 1 (Newcastle disease) vaccine
Ascorbate dihydrate, calcium....................................... 11.2-4874 (live) .............................................................................. 11.1-4608
Ascorbate, sodium ......................................................... 11.2-4945 Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1131
Ascorbic acid .................................................................. 11.2-4865 Avian tuberculin purified protein derivative....................... 4303
Ascorbyl palmitate.................................................................. 1999 Avian viral tenosynovitis vaccine (live) ...................... 11.1-4602
Ash insoluble in hydrochloric acid (2.8.1.) ........................... 321 Azaperone for veterinary use ................................................ 2021
Ash leaf .................................................................................... 1392 Azathioprine............................................................................ 2022
Ash, sulfated (2.4.14.)............................................................... 152 Azelastine hydrochloride ....................................................... 2023
Ash, total (2.4.16.) .................................................................... 153 Azithromycin .......................................................................... 2025
Asparagine monohydrate....................................................... 2000
Aspartame................................................................................ 2001 B
Aspartic acid............................................................................ 2003 B19 virus (B19V), validation of nucleic acid amplification
Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 323 techniques for the quantification of B19V DNA in plasma
Assay of Bet v 1 allergen (2.7.36.)........................................... 317 pools : guidelines..................................................................... 236
Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 285 Bacampicillin hydrochloride ................................................. 2031
Assay of heparin (2.7.5.) .......................................................... 285 Bacitracin................................................................................. 2033
Assay of heparin in coagulation factors (2.7.12.) ................. 297 Bacitracin zinc......................................................................... 2037
Assay of hepatitis A vaccine (2.7.14.)..................................... 300 Baclofen ................................................................................... 2041
Assay of hepatitis B vaccine (rDNA) (2.7.15.)....................... 300 Bacterial endotoxins (2.6.14.).................................................. 226
Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 315 Bacterial endotoxins, guidelines for using the test for
Assay of human anti-D immunoglobulin (2.7.13.) .............. 298 (5.1.10.) .................................................................................... 669
Assay of human antithrombin III (2.7.17.)............................ 303 Bacterial endotoxins using recombinant factor C, test for
Assay of human C1-esterase inhibitor (2.7.34.) .................... 316 (2.6.32.) .................................................................................... 252
Assay of human coagulation factor II (2.7.18.)..................... 303 Bactericidal, fungicidal or yeasticidal activity of antiseptic
Assay of human coagulation factor IX (2.7.11.) ................... 297 medicinal products, determination of (5.1.11.) .................. 673
Assay of human coagulation factor VII (2.7.10.).................. 296 Baical skullcap root ................................................................ 1399
Assay of human coagulation factor VIII (2.7.4.) .................. 284 Balances for analytical purposes (2.1.7.) ................................. 20
Assay of human coagulation factor X (2.7.19.) ..................... 304 Bambuterol hydrochloride .................................................... 2042
Assay of human coagulation factor XI (2.7.22.) ................... 307 Barbados aloes ........................................................................ 1369
Assay of human plasmin inhibitor (2.7.25.).......................... 310 Barbary wolfberry fruit.......................................................... 1401
Assay of human protein C (2.7.30.)........................................ 314 Barium chloratum for homoeopathic preparations ........... 1816
Assay of human protein S (2.7.31.) ........................................ 315 Barium chloride dihydrate for homoeopathic
Assay of human von Willebrand factor (2.7.21.).................. 305 preparations .......................................................................... 1816
Assay of interferons (5.6.)........................................................ 777 Barium sulfate ......................................................................... 2043
Assay of pertussis vaccine (acellular) (2.7.16.)...................... 301 Basic butylated methacrylate copolymer ............................. 2044
Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 290 BCG for immunotherapy....................................................... 1014
Assay of poliomyelitis vaccine (inactivated), in vivo BCG vaccine, freeze-dried..................................................... 1015
(2.7.20.) .................................................................................... 304 Bearberry leaf.......................................................................... 1402
Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 291 Beclometasone dipropionate ................................................. 2045
Assays (2.5.)............................................................................... 179 Beclometasone dipropionate monohydrate......................... 2048
Astragalus mongholicus root ................................................ 1393 Beeswax, white ........................................................................ 2051
Atazanavir sulfate ................................................................... 2005 Beeswax, yellow....................................................................... 2051
Atenolol.................................................................................... 2007 Belamcanda chinensis rhizome............................................. 1403
Atomic absorption spectrometry (2.2.23.) .............................. 43 Belladonna for homoeopathic preparations........................ 1816
Atomic emission spectrometry (2.2.22.).................................. 42 Belladonna leaf........................................................................ 1405
Atomic emission spectrometry, inductively coupled plasma- Belladonna leaf dry extract, standardised ........................... 1406
(2.2.57.) .................................................................................... 116 Belladonna leaf tincture, standardised................................. 1408
Atomoxetine hydrochloride .................................................. 2009 Belladonna, prepared ............................................................. 1409
Atorvastatin calcium ..................................................... 11.1-4642 Benazepril hydrochloride ...................................................... 2052
Atovaquone.............................................................................. 2013 Bendroflumethiazide.............................................................. 2054
Atractylodes lancea rhizome ................................................. 1395 Benperidol ............................................................................... 2055
Atractylodes rhizome, largehead .......................................... 1396 Benserazide hydrochloride .................................................... 2056
Atracurium besilate ................................................................ 2015 Bentonite.................................................................................. 2057
Atropine ................................................................................... 2018 Benzalkonium chloride.......................................................... 2058
Atropine sulfate....................................................................... 2019 Benzalkonium chloride solution........................................... 2060
Aucklandia root ...................................................................... 1398 Benzathine benzylpenicillin tetrahydrate ............................ 2071
Aujeszky’s disease vaccine (inactivated) for pigs ................ 1119 Benzathine penicillin G tetrahydrate ................................... 2071
Aujeszky’s disease vaccine (live) for pigs for parenteral Benzathine penicillin V tetrahydrate ................................... 3688
administration....................................................................... 1121 Benzathine phenoxymethylpenicillin tetrahydrate ............ 3688
Aurothiomalate, sodium ........................................................ 3975 Benzbromarone....................................................................... 2062
Aurum chloratum natronatum for homoeopathic Benzenesulfonate (methyl, ethyl and isopropyl) in active
preparations .......................................................................... 1815 substances (2.5.41.)................................................................. 198

Benzethonium chloride ......................................................... 2063 Blackcurrant leaf ..................................................................... 1430

Benzocaine............................................................................... 2064 Bleomycin sulfate.................................................................... 2108
Benzoic acid ............................................................................ 2065 Blood and blood components, human, empty sterile containers
Benzoin, Siam ......................................................................... 1410 of plasticised poly(vinyl chloride) for (3.3.5.)..................... 499
Benzoin, Sumatra.................................................................... 1411 Blood and blood components, human, materials based
Benzoin tincture, Siam........................................................... 1411 on plasticised poly(vinyl chloride) for containers for
Benzoin tincture, Sumatra..................................................... 1412 (3.3.2.) ...................................................................................... 491
Benzoyl peroxide, hydrous .................................................... 2066 Blood and blood components, human, materials for containers
Benzydamine hydrochloride ........................................ 11.1-4649 for (3.3.1.) ................................................................................ 491
Benzyl alcohol ......................................................................... 2069 Blood and blood components, human, sterile plastic
Benzyl benzoate ...................................................................... 2070 containers for (3.3.4.)............................................................. 497
Benzylpenicillin (benzathine) tetrahydrate ......................... 2071 Blood and blood components, materials based on plasticised
Benzylpenicillin potassium ................................................... 2073 poly(vinyl chloride) for tubing used in sets for the transfusion
Benzylpenicillin (procaine) monohydrate........................... 2075 of (3.3.3.).................................................................................. 494
Benzylpenicillin sodium ........................................................ 2077 Blood and blood components, sets for the transfusion of
Berberis aristata stem.................................................... 11.1-4623 (3.3.7.) ...................................................................................... 501
Betacarotene ............................................................................ 2079 Blood containing anticoagulant solution, human, sterile
Betacyclodextrin ..................................................................... 2080 containers of plasticised poly(vinyl chloride) for (3.3.6.).. 500
Betacyclodextrin, poly(hydroxypropyl) ether ..................... 3041 Blood, human anticoagulant and preservative solutions
Betacyclodextrin, sodium 4-sulfonatobutyl ether .............. 4110 for ........................................................................................... 1975
Betadex..................................................................................... 2080 Bogbean leaf ............................................................................ 1431
Betahistine dihydrochloride.................................................. 2082 Boiling point (2.2.12.) ................................................................ 37
Betahistine mesilate................................................................ 2083 Boldine ..................................................................................... 2109
Betamethasone ........................................................................ 2084 Boldo leaf................................................................................. 1431
Betamethasone acetate ........................................................... 2086 Boldo leaf dry extract............................................................. 1433
Betamethasone dipropionate................................................. 2087 Borage (starflower) oil, refined ............................................. 2111
Betamethasone sodium phosphate....................................... 2089 Borax ........................................................................................ 2111
Betamethasone valerate ......................................................... 2091 Bordetella bronchiseptica vaccine (live) for dogs............... 1134
Betaxolol hydrochloride......................................................... 2092 Boric acid................................................................................. 2112
Betiatide for radiopharmaceutical preparations ................. 1248 Botulinum antitoxin ............................................................... 1233
Bezafibrate ............................................................................... 2094 Botulinum toxin type A for injection................................... 2112
Bicalutamide............................................................................ 2095 Botulinum toxin type B for injection ................................... 2114
Bifonazole ................................................................................ 2097 Bovine leptospirosis vaccine (inactivated) .......................... 1135
Bilberry fruit, dried ................................................................ 1413 Bovine parainfluenza virus vaccine (live)............................ 1136
Bilberry fruit dry extract, fresh, refined and standardised.. 1520 Bovine respiratory syncytial virus vaccine (live) ................ 1137
Bilberry fruit, fresh................................................................. 1414 Bovine rhinotracheitis vaccine (inactivated), infectious ... 1183
Biological assays (2.7.) ............................................................. 277 Bovine rhinotracheitis vaccine (live), infectious ................ 1184
Biological assays and tests, statistical analysis of results of Bovine serum .......................................................................... 2115
(5.3.) ......................................................................................... 721 Bovine tuberculin purified protein derivative..................... 4303
Biological indicators and related microbial preparations used Bovine viral diarrhoea vaccine (inactivated) ...................... 1138
in the manufacture of sterile products (5.1.2.) ................... 652 Brimonidine tartrate .............................................................. 2117
Biological products, general texts on (5.2.) ........................... 679 Bromazepam ........................................................................... 2118
Biological products, terminology used in monographs on Bromhexine hydrochloride.................................................... 2119
(5.2.1.) ...................................................................................... 679 Bromocriptine mesilate.......................................................... 2121
Biological tests (2.6.) ................................................................ 207 Bromperidol ............................................................................ 2123
Biotherapeutic products for human use, live ........................ 935 Bromperidol decanoate.......................................................... 2124
Biotherapeutic products (live), microbiological examination of Brompheniramine maleate .................................................... 2126
(tests for enumeration of microbial contaminants) (2.6.36.) Bronchitis vaccine (inactivated), infectious, avian ............. 1123
.................................................................................................. 262 Bronchitis vaccine (live), infectious, avian ................. 11.1-4597
Biotherapeutic products (live), microbiological examination Brotizolam ............................................................................... 2127
of (tests for specified micro-organisms) (2.6.38.)............... 267 Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for
Biotin........................................................................................ 2098 veterinary use........................................................................ 1140
Biperiden hydrochloride........................................................ 2100 Bryonia for homoeopathic preparations.............................. 1818
Biphasic isophane insulin injection...................................... 3092 Buccal films ............................................................................... 987
Birch leaf .................................................................................. 1415 Buccal tablets and sublingual tablets...................................... 987
Bisacodyl.................................................................................. 2101 Buccal tablets, mucoadhesive.................................................. 987
Bismuth subcarbonate............................................................ 2102 Buckwheat herb ...................................................................... 1434
Bismuth subgallate.................................................................. 2103 Budesonide .............................................................................. 2128
Bismuth subnitrate, heavy ..................................................... 2104 Bufexamac ............................................................................... 2131
Bismuth subsalicylate............................................................. 2105 Buffer solutions (4.1.3.)............................................................ 632
Bisoprolol fumarate ................................................................ 2106 Buflomedil hydrochloride...................................................... 2132
Bistort rhizome ....................................................................... 1416 Bulk density and tapped density of powders (2.9.34.) ......... 407
Bitter apricot seed................................................................... 1417 Bumetanide ............................................................................. 2133
Bitter fennel ............................................................................. 1508 Bupivacaine hydrochloride........................................... 11.2-4869
Bitter-fennel fruit oil .............................................................. 1419 Bupleurum root ...................................................................... 1435
Bitter-fennel herb oil .............................................................. 1420 Buprenorphine ........................................................................ 2136
Bitterness value (2.8.15.) .......................................................... 326 Buprenorphine hydrochloride .............................................. 2138
Bitter-orange epicarp and mesocarp .................................... 1423 Bursal disease vaccine (inactivated), infectious, avian....... 1126
Bitter-orange flower................................................................ 1424 Bursal disease vaccine (live), infectious, avian........... 11.1-4598
Bitter-orange-epicarp and mesocarp tincture..................... 1424 Buserelin .................................................................................. 2140
Bitter-orange-flower oil.......................................................... 1634 Buspirone hydrochloride ....................................................... 2142
Black cohosh............................................................................ 1425 Busulfan ................................................................................... 2144
Black horehound..................................................................... 1428 Butcher’s broom ...................................................................... 1437
Butyl parahydroxybenzoate................................................... 2144 Capillary viscometer method (2.2.9.)....................................... 33

Butylated methacrylate copolymer, basic ............................ 2044 Caprylate, sodium................................................................... 3979
Butylhydroxyanisole ............................................................... 2146 Caprylic acid ........................................................................... 2194
Butylhydroxytoluene .............................................................. 2147 Caprylocaproyl macrogolglycerides ..................................... 2195
Capsicum ................................................................................. 1442
C Capsicum oleoresin, refined and standardised ................... 1443
Cabergoline ............................................................................. 2151 Capsicum soft extract, standardised .................................... 1444
Cachets....................................................................................... 967 Capsicum tincture, standardised .......................................... 1445
Cadmium sulfate hydrate for homoeopathic prepara- Capsules ..................................................................................... 966
tions........................................................................................ 1819 Capsules and tablets, disintegration of (2.9.1.) ..................... 345
Cadmium sulfuricum for homoeopathic preparations...... 1819 Capsules, gastro-resistant ........................................................ 967
Caffeine .................................................................................... 2152 Capsules, hard ........................................................................... 966
Caffeine monohydrate............................................................ 2153 Capsules, intrauterine .............................................................. 975
Calcifediol monohydrate ....................................................... 2155 Capsules, modified-release ...................................................... 967
Calcipotriol.............................................................................. 2156 Capsules, oromucosal............................................................... 987
Calcipotriol monohydrate ..................................................... 2158 Capsules, rectal ....................................................................... 1000
Calcitonin (salmon)................................................................ 2161 Capsules, soft............................................................................. 966
Calcitriol .................................................................................. 2163 Capsules, vaginal............................................................ 11.1-4594
Calcium (2.4.3.)......................................................................... 148 Captopril .................................................................................. 2196
Calcium acetate.............................................................. 11.2-4873 Caraway fruit........................................................................... 1446
Calcium ascorbate dihydrate........................................ 11.2-4874 Caraway oil .............................................................................. 1447
Calcium carbonate.................................................................. 2166 Carbachol................................................................................. 2198
Calcium carboxymethylcellulose .......................................... 2213 Carbamazepine ....................................................................... 2199
Calcium chloride dihydrate.......................................... 11.2-4876 Carbasalate calcium................................................................ 2200
Calcium chloride hexahydrate ..................................... 11.2-4876 Carbidopa ................................................................................ 2202
Calcium dobesilate monohydrate ......................................... 2168 Carbimazole ............................................................................ 2204
Calcium edetate, sodium ....................................................... 3978 Carbocisteine........................................................................... 2205
Calcium fluoratum for homoeopathic preparations .......... 1820 Carbomers ............................................................................... 2206
Calcium folinate hydrate........................................................ 2169 Carbon dioxide ....................................................................... 2207
Calcium glucoheptonate ........................................................ 2171 Carbon dioxide in gases (2.5.24.) ........................................... 186
Calcium gluconate .................................................................. 2172 Carbon monoxide................................................................... 2209
Calcium gluconate, anhydrous.............................................. 2173 Carbon monoxide (15O) ......................................................... 1249
Calcium gluconate for injection ........................................... 2173 Carbon monoxide in gases (2.5.25.)....................................... 187
Calcium glycerophosphate .................................................... 2175 Carbon monoxide intermix (5 per cent) in nitrogen ......... 2210
Calcium hydrogen phosphate ............................................... 2175 Carboplatin.............................................................................. 2210
Calcium hydrogen phosphate dihydrate.............................. 2176 Carboprost trometamol ......................................................... 2211
Calcium hydroxide ................................................................. 2177 Carboxymethylcellulose......................................................... 2212
Calcium in adsorbed vaccines (2.5.14.) ................................. 184 Carboxymethylcellulose calcium .......................................... 2213
Calcium iodatum for homoeopathic preparations ............. 1820 Carboxymethylcellulose sodium........................................... 2213
Calcium iodide tetrahydrate for homoeopathic Carboxymethylcellulose sodium, cross-linked ................... 2436
preparations .......................................................................... 1820 Carboxymethylcellulose sodium, low-substituted.............. 2214
Calcium lactate........................................................................ 2178 Carmellose............................................................................... 2212
Calcium lactate monohydrate ............................................... 2179 Carmellose calcium ................................................................ 2213
Calcium lactate pentahydrate................................................ 2179 Carmellose sodium................................................................. 2213
Calcium lactate trihydrate ..................................................... 2180 Carmellose sodium and microcrystalline cellulose............ 3415
Calcium levofolinate hydrate ................................................ 2180 Carmellose sodium, low-substituted.................................... 2214
Calcium levulinate dihydrate ................................................ 2183 Carmustine .............................................................................. 2215
Calcium pantothenate ................................................... 11.2-4877 Carnauba wax.......................................................................... 2216
Calcium pentetate (sodium) hydrate for radiopharmaceutical Carprofen for veterinary use ................................................. 2217
preparations .......................................................................... 1290 Carrageenan ............................................................................ 2218
Calcium phosphate................................................................. 2185 Carrier proteins for the production of conjugated
Calcium stearate ..................................................................... 2186 polysaccharide vaccines for human use (5.2.11.) ............... 711
Calcium sulfate dihydrate...................................................... 2187 Carteolol hydrochloride......................................................... 2219
Calendula flower..................................................................... 1438 Carvedilol ................................................................................ 2221
Calf coronavirus diarrhoea vaccine (inactivated)............... 1141 Cascara..................................................................................... 1448
Calf rotavirus diarrhoea vaccine (inactivated).................... 1142 Cascara dry extract, standardised......................................... 1450
Calicivirosis vaccine (inactivated), feline ............................ 1169 Cassia oil .................................................................................. 1451
Calicivirosis vaccine (live), feline ......................................... 1170 Castor oil, hydrogenated........................................................ 2222
Camphor, D-............................................................................ 2188 Castor oil, polyoxyl................................................................. 3289
Camphor, racemic .................................................................. 2189 Castor oil, polyoxyl hydrogenated........................................ 3288
Candesartan cilexetil .............................................................. 2190 Castor oil, refined ................................................................... 2223
Canine adenovirus vaccine (inactivated)............................. 1143 Castor oil, virgin ..................................................................... 2224
Canine adenovirus vaccine (live).......................................... 1144 Catgut, sterile .......................................................................... 1339
Canine distemper vaccine (live) ........................................... 1145 Catgut, sterile, in distributor for veterinary use ................. 1349
Canine leptospirosis vaccine (inactivated) .......................... 1146 CD34/CD45+ cells in haematopoietic products, numeration
Canine parainfluenza virus vaccine (live) ........................... 1147 of (2.7.23.)................................................................................ 307
Canine parvovirosis vaccine (inactivated)........................... 1148 Cefaclor.................................................................................... 2225
Canine parvovirosis vaccine (live)........................................ 1149 Cefadroxil monohydrate........................................................ 2226
Cape aloes................................................................................ 1370 Cefalexin monohydrate.......................................................... 2228
Cape jasmine fruit .................................................................. 1440 Cefalotin sodium ........................................................... 11.1-4653
Capecitabine............................................................................ 2192 Cefamandole nafate................................................................ 2231
Capillary electrophoresis (2.2.47.) ............................................ 96 Cefapirin sodium.................................................................... 2232
Cefatrizine propylene glycol.................................................. 2233

Cefazolin sodium.................................................................... 2234 Chinese motherwort .............................................................. 1459

Cefepime dihydrochloride monohydrate ............................ 2237 Chitosan hydrochloride ......................................................... 2285
Cefixime................................................................................... 2239 Chlamydiosis vaccine (inactivated), feline ......................... 1171
Cefoperazone sodium ............................................................ 2240 Chloral hydrate ....................................................................... 2286
Cefotaxime sodium ................................................................ 2242 Chlorambucil .......................................................................... 2287
Cefoxitin sodium .................................................................... 2244 Chloramine.............................................................................. 4254
Cefpodoxime proxetil ............................................................ 2246 Chloramphenicol .................................................................... 2288
Cefprozil monohydrate .......................................................... 2248 Chloramphenicol palmitate................................................... 2289
Cefradine ................................................................................. 2250 Chloramphenicol sodium succinate..................................... 2291
Ceftazidime pentahydrate...................................................... 2252 Chlorcyclizine hydrochloride................................................ 2292
Ceftazidime pentahydrate with sodium carbonate for Chlordiazepoxide.................................................................... 2293
injection ................................................................................. 2254 Chlordiazepoxide hydrochloride .......................................... 2294
Ceftriaxone sodium................................................................ 2257 Chlorhexidine diacetate ......................................................... 2295
Cefuroxime axetil ................................................................... 2258 Chlorhexidine digluconate solution ..................................... 2297
Cefuroxime sodium................................................................ 2259 Chlorhexidine dihydrochloride ............................................ 2299
Celandine, greater.......................................................... 11.1-4626 Chlorides (2.4.4.) ...................................................................... 148
Celecoxib ................................................................................. 2261 Chlormadinone acetate.......................................................... 2302
Celiprolol hydrochloride ....................................................... 2262 Chlorobutanol ......................................................................... 2303
Cell count and viability, nucleated (2.7.29.).......................... 312 Chlorobutanol hemihydrate .................................................. 2304
Cell cultures for the production of vaccines for veterinary use Chlorocresol ............................................................................ 2306
(5.2.4.) ...................................................................................... 686 Chloroquine phosphate ......................................................... 2306
Cell substrates for the production of vaccines for human use Chloroquine sulfate ................................................................ 2307
(5.2.3.) ...................................................................................... 682 Chlorphenamine maleate ...................................................... 2308
Cell-based and gene therapy medicinal products, raw materials Chlorpromazine hydrochloride ............................................ 2309
of biological origin for the production of (5.2.12.) ............ 712 Chlorprothixene hydrochloride ............................................ 2311
Cell-based assays for potency determination of TNF-alpha Chlortalidone .......................................................................... 2312
antagonists (2.7.26.) .................................................... 11.1-4513 Chlortetracycline hydrochloride........................................... 2314
Cell-based preparations, microbiological examination of Cholecalciferol ........................................................................ 2316
(2.6.27.) .................................................................................... 241 Cholecalciferol concentrate (oily form)............................... 2318
Cellulose acetate ..................................................................... 2263 Cholecalciferol concentrate (powder form) ........................ 2319
Cellulose acetate butyrate ...................................................... 2264 Cholera vaccine (inactivated), fowl ...................................... 1180
Cellulose acetate phthalate .................................................... 2265 Cholera vaccine (inactivated, oral)....................................... 1017
Cellulose, microcrystalline .................................................... 2266 Cholesterol............................................................................... 2320
Cellulose (microcrystalline) and carmellose sodium......... 3415 Cholesterol for parenteral use ............................................... 2321
Cellulose, powdered ............................................................... 2270 Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 174
Centaury .................................................................................. 1452 Choline ([11C]methyl) injection............................................ 1250
Centella .................................................................................... 1453 Chondroitin sulfate sodium .................................................. 2323
Cetirizine dihydrochloride .................................................... 2274 Chromatographic separation techniques (2.2.46.) ................. 86
Cetostearyl alcohol ................................................................. 2275 Chromatography, gas (2.2.28.)..................................... 11.1-4502
Cetostearyl alcohol (type A), emulsifying ........................... 2276 Chromatography, liquid (2.2.29.) ................................ 11.1-4503
Cetostearyl alcohol (type B), emulsifying............................ 2277 Chromatography, paper (2.2.26.) ............................................. 52
Cetostearyl isononanoate ...................................................... 2279 Chromatography, size-exclusion (2.2.30.) .................. 11.1-4505
Cetostearyl sulfate, sodium ................................................... 3981 Chromatography, supercritical fluid (2.2.45.)............ 11.1-4505
Cetrimide................................................................................. 2279 Chromatography, thin-layer (2.2.27.) ......................... 11.1-4501
Cetyl alcohol............................................................................ 2280 Chromium (51Cr) edetate injection ...................................... 1251
Cetyl palmitate ........................................................................ 2280 Chymotrypsin ......................................................................... 2325
Cetylpyridinium chloride ...................................................... 2281 Ciclesonide .............................................................................. 2327
Ceylon cinnamon bark oil..................................................... 1464 Ciclopirox ................................................................................ 2328
Ceylon cinnamon leaf oil....................................................... 1465 Ciclopirox olamine ................................................................. 2329
CFC assay for human haematopoietic progenitor cells Ciclosporin .............................................................................. 2331
(2.7.28.) .................................................................................... 311 Cilastatin sodium.................................................................... 2332
Chaenomeles fruit .................................................................. 1455 Cilazapril.................................................................................. 2334
Chamomile flower, Roman ................................................... 1456 Cimetidine ............................................................................... 2336
Characterisation of crystalline and partially crystalline solids Cimetidine hydrochloride ..................................................... 2337
by X-ray powder diffraction (XRPD) (2.9.33.) ................... 402 Cinchocaine hydrochloride ................................................... 2339
Characterisation of crystalline solids by microcalorimetry and Cinchona bark......................................................................... 1461
solution calorimetry (2.2.61.)................................................ 124 Cinchona liquid extract, standardised ................................. 1462
Characterisation of preparations for nebulisation (2.9.44.).. 427 Cineole ..................................................................................... 2341
Characters section in monographs (5.11.) ............................ 805 Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 323
Charcoal, activated ................................................................. 2282 Cineole type niaouli oil.......................................................... 1638
Chemical imaging (5.24.) ........................................................ 889 Cinnamon................................................................................ 1463
Chemical precursors for radiopharmaceutical Cinnamon bark oil, Ceylon................................................... 1464
preparations ............................................................................ 920 Cinnamon leaf oil, Ceylon..................................................... 1465
Chemometric methods applied to analytical data Cinnarizine.............................................................................. 2342
(5.21.) ............................................................................ 11.1-4545 Ciprofibrate ............................................................................. 2343
Chenodeoxycholic acid .......................................................... 2283 Ciprofloxacin........................................................................... 2344
Chewable tablets ..................................................................... 1006 Ciprofloxacin hydrochloride ................................................. 2346
Chewing gums, medicated ...................................................... 967 Circular dichroism (2.2.41.) ...................................................... 81
Chewing gums, medicated, dissolution test for (2.9.25.)..... 387 Cisatracurium besilate ........................................................... 2347
Chicken anaemia vaccine (live), infectious ................ 11.1-4606 Cisplatin................................................................................... 2351
Chicken flocks free from specified pathogens for the production Citalopram hydrobromide..................................................... 2353
and quality control of vaccines (5.2.2.)..................... 11.1-4539 Citalopram hydrochloride ..................................................... 2354
Chinese goldthread rhizome ................................................. 1458 Citric acid ................................................................................ 2356
Citric acid monohydrate ........................................................ 2356 Coccidiosis vaccine (live) for chickens ................................ 1157
Citronella oil............................................................................ 1466 Cocculus for homoeopathic preparations ........................... 1821
Cladribine ................................................................................ 2357 Cocoa butter............................................................................ 2399
Clarithromycin........................................................................ 2359 Coconut oil, refined................................................................ 2400
Clarity and degree of opalescence of liquids (2.2.1.).............. 25 Cocoyl caprylocaprate............................................................ 2401
Clary sage oil ........................................................................... 1467 Codeine hydrochloride dihydrate......................................... 2402
Classical swine-fever vaccine (live, prepared in cell Codeine monohydrate............................................................ 2404
cultures) ................................................................................. 1221 Codeine phosphate hemihydrate .......................................... 2406
Clazuril for veterinary use..................................................... 2362 Codeine phosphate sesquihydrate ........................................ 2408
Clebopride malate .................................................................. 2363 Codergocrine mesilate ........................................................... 2411
Clemastine fumarate .............................................................. 2365 Cod-liver oil ............................................................................ 2413
Clematis armandii stem ......................................................... 1467 Cod-liver oil, farmed.............................................................. 2417
Clenbuterol hydrochloride .................................................... 2366 Codonopsis root ..................................................................... 1471
Clindamycin hydrochloride .................................................. 2367 Coix seed.................................................................................. 1472
Clindamycin phosphate ................................................ 11.2-4878 Cola .......................................................................................... 1473
Clioquinol................................................................................ 2372 Colchicine................................................................................ 2421
Clobazam ................................................................................. 2373 Cold-water vibriosis vaccine (inactivated) for salmonids.. 1225
Clobetasol propionate ............................................................ 2374 Colestyramine ......................................................................... 2423
Clobetasone butyrate.............................................................. 2376 Colibacillosis vaccine (inactivated), neonatal piglet .......... 1194
Clodronate disodium tetrahydrate .............................. 11.2-4881 Colibacillosis vaccine (inactivated), neonatal ruminant.... 1196
Clofazimine ............................................................................. 2378 Colistimethate sodium.................................................. 11.1-4654
Clofibrate ................................................................................. 2379 Colistin sulfate ............................................................... 11.1-4657
Clomifene citrate .................................................................... 2380 Colloidal anhydrous silica ..................................................... 3959
Clomipramine hydrochloride ............................................... 2382 Colloidal hydrated silica ........................................................ 3959
Clonazepam............................................................................. 2384 Colloidal silica, hydrophobic ................................................ 3961
Clonidine hydrochloride........................................................ 2385 Colloidal silver ........................................................................ 3961
Clopamide ............................................................................... 2386 Colony-forming cell assay for human haematopoietic
Clopidogrel besilate................................................................ 2387 progenitor cells (2.7.28.) ........................................................ 311
Clopidogrel hydrochloride .................................................... 2389 Colophony ............................................................................... 1474
Clopidogrel hydrogen sulfate ................................................ 2391 Coloration of liquids (2.2.2.) ..................................................... 26
Clorazepate, dipotassium monohydrate .............................. 2566 Common selfheal fruit-spike ................................................ 1474
Closantel sodium dihydrate for veterinary use................... 2392 Common stinging nettle for homoeopathic preparations.. 1849
Clostridium botulinum vaccine for veterinary use ... 11.2-4849 Comparative table of porosity of sintered-glass filters
Clostridium chauvoei vaccine for veterinary use ............... 1151 (2.1.2.) ........................................................................................ 17
Clostridium novyi (type B) vaccine for veterinary use...... 1152 Complexometric titrations (2.5.11.) ....................................... 182
Clostridium perfringens vaccine for veterinary use........... 1153 Composition of fatty acids by gas chromatography
Clostridium septicum vaccine for veterinary use............... 1155 (2.4.22.) .................................................................................... 157
Closures and containers for parenteral preparations and Composition of fatty acids in oils rich in omega-3 acids
ophthalmic preparations, polypropylene for (3.1.6.) ......... 457 (2.4.29.) .................................................................................... 171
Closures and containers for pharmaceutical use, plastic Compressed lozenges ............................................................... 987
(3.2.2.) ...................................................................................... 485 Concentrated solutions for haemodialysis .......................... 2936
Closures and tubing, silicone elastomer for (3.1.9.)............. 462 Concentrated solutions for haemofiltration and
Closures for containers for aqueous parenteral preparations, haemodiafiltration ................................................................ 2939
for powders and for freeze-dried powders, rubber Concentrates for injections or infusions................................ 989
(3.2.9.) ........................................................................... 11.1-4529 Concentrates for intrauterine solutions ................................. 975
Clotrimazole............................................................................ 2394 Concentrates for intravesical solutions, suspensions or
Clove......................................................................................... 1469 emulsions................................................................................. 978
Clove oil ................................................................................... 1470 Conductivity (2.2.38.) ................................................................ 72
Cloxacillin sodium ................................................................. 2396 Coneflower herb, purple ........................................................ 1679
Clozapine ................................................................................. 2397 Coneflower herb, purple, expressed juice, stabilised with
Coagulation factor II, human, assay of (2.7.18.)................... 303 ethanol ................................................................................... 1681
Coagulation factor IX, human .............................................. 2985 Coneflower herb, purple, expressed juice, stabilised without
Coagulation factor IX, human, assay of (2.7.11.) ................. 297 ethanol .......................................................................... 11.1-4630
Coagulation factor IX (rDNA) concentrated solution, Coneflower root, narrow-leaved ........................................... 1632
human .................................................................................... 2986 Coneflower root, pale............................................................. 1655
Coagulation factor IX (rDNA) powder for solution for Coneflower root, purple......................................................... 1684
injection, human................................................................... 2991 Conjugated estrogens ............................................................. 2694
Coagulation factor VII, human............................................. 2977 Conjugated polysaccharide vaccines for human use, carrier
Coagulation factor VII, human, assay of (2.7.10.)................ 296 proteins for the production of (5.2.11.) ............................... 711
Coagulation factor VIIa (rDNA) concentrated solution, Consistency by penetrometry, measurement of (2.9.9.)...... 360
human .................................................................................... 2978 Containers (3.2.) ....................................................................... 479
Coagulation factor VIII, human ........................................... 2983 Containers and closures for parenteral preparations and
Coagulation factor VIII, human, assay of (2.7.4.) ................ 284 ophthalmic preparations, polypropylene for (3.1.6.) ......... 457
Coagulation factor VIII (rDNA), human ............................ 2984 Containers and closures for pharmaceutical use, plastic
Coagulation factor X, assay of (2.7.19.) ................................. 304 (3.2.2.) ...................................................................................... 485
Coagulation factor XI, human .............................................. 2994 Containers and tubing for total parenteral nutrition
Coagulation factor XI, human, assay of (2.7.22.) ................. 307 preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 460
Coagulation factors, activated (2.6.22.) ................................. 240 Containers for aqueous solutions for infusion, plastic
Coagulation factors, assay of heparin (2.7.12.) ..................... 297 (3.2.2.1.) ................................................................................... 486
Coated granules ........................................................................ 974 Containers for aqueous solutions for intravenous infusion,
Coated tablets.......................................................................... 1005 materials based on, plasticised poly(vinyl chloride) for
Cocaine hydrochloride........................................................... 2398 (3.1.14.) .................................................................................... 471

Containers for human blood and blood components, and Creams ..................................................................................... 1003
materials used in their manufacture ; transfusion sets and Cresol, crude ........................................................................... 2435
materials used in their manufacture ; syringes (3.3.) ......... 491 Crocus for homoeopathic preparations ............................... 1822
Containers for human blood and blood components, materials Cromoglicate, sodium............................................................ 3985
based on plasticised poly(vinyl chloride) for (3.3.2.)......... 491 Croscarmellose sodium ......................................................... 2436
Containers for human blood and blood components, materials Crospovidone .......................................................................... 2437
for (3.3.1.) ................................................................................ 491 Crotamiton ..................................................................... 11.1-4659
Containers for human blood and blood components, plastic, Crystalline and partially crystalline solids, characterisation
sterile (3.3.4.)........................................................................... 497 by X-ray powder diffraction (XRPD) of (2.9.33.)............... 402
Containers for non-injectable aqueous solutions, materials Crystalline solids, characterisation by microcalorimetry and
based on non-plasticised poly(vinyl chloride) for solution calorimetry (2.2.61.)................................................ 124
(3.1.10.) .................................................................................... 463 Crystallinity (5.16.)................................................................... 833
Containers for parenteral preparations and for ophthalmic Cuprum aceticum for homoeopathic preparations............ 1823
preparations, polyethylene with additives for (3.1.5.)........ 453 Cuprum metallicum for homoeopathic preparations........ 1824
Containers for parenteral preparations and for ophthalmic Cutaneous application, liquid preparations for .................... 978
preparations, polyethylene without additives for (3.1.4.).. 452 Cutaneous application, powders for....................................... 991
Containers for pharmaceutical use, glass (3.2.1.) ................. 479 Cutaneous application, semi-solid preparations for .......... 1001
Containers for preparations not for parenteral use, Cutaneous application, veterinary liquid preparations
polyethylene terephthalate for (3.1.15) ................................ 474 for ........................................................................................... 1008
Containers for solid dosage forms for oral administration, Cutaneous foams ...................................................................... 980
materials based on non-plasticised poly(vinyl chloride) for Cutaneous patches .................................................................... 990
(3.1.11.) .................................................................................... 465 Cyanocobalamin ..................................................................... 2440
Containers, materials used for the manufacture of (3.1.).... 449 Cyanocobalamin (57Co) capsules .......................................... 1253
Containers of plasticised poly(vinyl chloride) for human blood Cyanocobalamin (57Co) solution .......................................... 1253
and blood components, empty sterile (3.3.5.)..................... 499 Cyanocobalamin (58Co) capsules .......................................... 1254
Containers of plasticised poly(vinyl chloride) for human blood Cyanocobalamin (58Co) solution .......................................... 1254
containing anticoagulant solution, sterile (3.3.6.) .............. 500 Cyathula root........................................................................... 1481
Contaminant pyrrolizidine alkaloids (2.8.26.)...................... 335 Cyclamate, sodium ................................................................. 3986
Contamination, microbial : microbial enumeration tests Cyclizine hydrochloride......................................................... 2442
(2.6.12.) .................................................................................... 217 Cyclopentolate hydrochloride ............................................... 2444
Contamination, microbial: microbial enumeration tests (live Cyclophosphamide monohydrate................................ 11.2-4882
biotherapeutic products) (2.6.36.) ........................................ 262 Cyproheptadine hydrochloride 1.5-hydrate ........................ 2447
Contamination, microbial : test for specified micro-organisms Cyproterone acetate................................................................ 2449
(2.6.13.) .................................................................................... 221 Cysteine hydrochloride monohydrate.................................. 2451
Contamination, microbial: tests for specified micro-organisms Cystine ..................................................................................... 2452
(live biotherapeutic products) (2.6.38.) ............................... 267 Cytarabine ............................................................................... 2454
Contamination, particulate, recommendations on testing of :
visible particles (5.17.2.) ....................................................... 839 D
Contamination, particulate : sub-visible particles (2.9.19.).. 382 Dacarbazine............................................................................. 2459
Contamination, particulate : sub-visible particles in Dalteparin sodium.................................................................. 2460
non-injectable liquid preparations (2.9.53.)........................ 441 Danaparoid sodium................................................................ 2462
Content uniformity of single-dose preparations (2.9.6.) ..... 358 Dandelion herb with root ...................................................... 1483
Control of impurities in substances for pharmaceutical use Dandelion root........................................................................ 1484
(5.10.) ....................................................................................... 799 Dapsone ................................................................................... 2464
Control of microbiological quality, alternative methods for Daunorubicin hydrochloride ................................................ 2465
(5.1.6.) ...................................................................................... 658 D-Camphor .............................................................................. 2188
Copolymer, basic butylated methacrylate ........................... 2044 Decyl oleate ............................................................................. 2467
Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 3284 Deferasirox .............................................................................. 2467
Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 3360 Deferasirox dispersible tablets .............................................. 2469
Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion Deferiprone .................................................................... 11.2-4887
30 per cent ............................................................................. 3361 Deferiprone oral solution ...................................................... 2472
Copolymer, methacrylic acid – methyl methacrylate Deferiprone tablets ................................................................. 2473
(1:1) ........................................................................................ 3362 Deferoxamine mesilate........................................................... 2474
Copolymer, methacrylic acid - methyl methacrylate Degree of coloration of liquids (2.2.2.) .................................... 26
(1:2) ........................................................................................ 3363 Delivery systems, vaginal.............................................. 11.1-4594
Copolymer (type A), ammonio methacrylate..................... 1949 Dembrexine hydrochloride monohydrate for veterinary
Copolymer (type B), ammonio methacrylate ..................... 1950 use........................................................................................... 2476
Copovidone ............................................................................. 2428 Demeclocycline hydrochloride ............................................. 2477
Copper acetate monohydrate for homoeopathic Demonstration of uniformity of dosage units using large
preparations .......................................................................... 1823 sample sizes (2.9.47.).............................................................. 432
Copper for homoeopathic preparations .............................. 1824 Density of powders, bulk density and tapped (2.9.34.)........ 407
Copper sulfate ......................................................................... 2431 Density of solids (2.2.42.) .......................................................... 82
Copper sulfate pentahydrate ................................................. 2432 Density of solids, gas pycnometric (2.9.23.).......................... 386
Copper tetramibi tetrafluoroborate for radiopharmaceutical Density, relative (2.2.5.) ............................................................. 31
preparations .......................................................................... 1252 Dental preparations.................................................................. 985
Coriander................................................................................. 1476 Dental type silica .................................................................... 3960
Coriander oil .................................................................. 11.1-4624 Depressor substances (2.6.11.) ................................................ 217
Coronavirus diarrhoea vaccine (inactivated), calf ............. 1141 Deptropine citrate................................................................... 2479
Cortisone acetate .................................................................... 2432 Depyrogenation of items used in the production of parenteral
Corydalis rhizome .................................................................. 1478 preparations (5.1.12.) ............................................................. 674
Cotton, absorbent ................................................................... 2434 Dequalinium chloride ............................................................ 2480
Cottonseed oil, hydrogenated .............................................. 2435 Desacyl-4′-monophosphoryl lipid A, 3-O-.......................... 2481
Couch grass rhizome.............................................................. 1480
Desflurane................................................................................ 2483 Dihydrotachysterol ................................................................. 2549

Desipramine hydrochloride................................................... 2485 Diltiazem hydrochloride........................................................ 2550
Deslanoside ............................................................................. 2486 Dimenhydrinate...................................................................... 2552
Desloratadine .......................................................................... 2487 Dimercaprol ............................................................................ 2554
Desmopressin .......................................................................... 2488 Dimethyl sulfoxide ................................................................. 2554
Desogestrel .............................................................................. 2489 Dimethylacetamide ................................................................ 2555
Detection and measurement of radioactivity (2.2.66.) ........ 129 Dimethylaniline, N,N- (2.4.26.) .............................................. 168
Detection, direct amperometric and pulsed electrochemical Dimeticone .............................................................................. 2556
(2.2.63.) .................................................................................... 126 Dimetindene maleate ............................................................. 2557
Detector tubes, gas (2.1.6.) ........................................................ 19 Dinoprost trometamol ........................................................... 2558
Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 327 Dinoprostone .......................................................................... 2559
Determination of bactericidal, fungicidal or yeasticidal activity Dioscorea nipponica rhizome ............................................... 1488
of antiseptic medicinal products (5.1.11.) ........................... 673 Dioscorea oppositifolia rhizome........................................... 1489
Determination of elemental impurities (2.4.20.) .................. 154 Diosmin ................................................................................... 2561
Determination of nitrogen by sulfuric acid digestion Dioxan and ethylene oxide (2.4.25.)....................................... 167
(2.5.9.) ...................................................................................... 182 Dip concentrates ..................................................................... 1008
Determination of primary aromatic amino-nitrogen Diphenhydramine hydrochloride ......................................... 2562
(2.5.8.) ...................................................................................... 181 Diphenoxylate hydrochloride................................................ 2564
Determination of water by distillation (2.2.13.) ..................... 37 Diphtheria and tetanus toxins and toxoids, flocculation value
Detomidine hydrochloride for veterinary use .................... 2490 (Lf) of, (Ramon assay) (2.7.27.)............................................ 310
Devil’s claw dry extract .......................................................... 1485 Diphtheria and tetanus vaccine (adsorbed) ........................ 1018
Devil’s claw root ...................................................................... 1485 Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)
Dexamethasone....................................................................... 2491 content).................................................................................. 1019
Dexamethasone acetate.......................................................... 2493 Diphtheria antitoxin............................................................... 1234
Dexamethasone isonicotinate ............................................... 2495 Diphtheria, tetanus and pertussis (acellular, component)
Dexamethasone sodium phosphate...................................... 2496 vaccine (adsorbed) ............................................................... 1021
Dexamfetamine sulfate .......................................................... 2498 Diphtheria, tetanus and pertussis (acellular, component)
Dexchlorpheniramine maleate.............................................. 2500 vaccine (adsorbed, reduced antigen(s) content)............... 1022
Dexpanthenol................................................................. 11.1-4663 Diphtheria, tetanus and pertussis (whole cell) vaccine
Dextran 1 for injection........................................................... 2503 (adsorbed) ............................................................................. 1023
Dextran 40 for injection......................................................... 2504 Diphtheria, tetanus and poliomyelitis (inactivated) vaccine
Dextran 60 for injection......................................................... 2505 (adsorbed, reduced antigen(s) content)............................. 1025
Dextran 70 for injection......................................................... 2506 Diphtheria, tetanus, pertussis (acellular, component) and
Dextranomer ........................................................................... 2506 haemophilus type b conjugate vaccine (adsorbed) .......... 1026
Dextrans, molecular mass distribution in (2.2.39.)................ 74 Diphtheria, tetanus, pertussis (acellular, component) and
Dextrin ..................................................................................... 2507 poliomyelitis (inactivated) vaccine (adsorbed)................. 1029
Dextromethorphan hydrobromide....................................... 2508 Diphtheria, tetanus, pertussis (acellular, component) and
Dextromoramide tartrate ...................................................... 2509 poliomyelitis (inactivated) vaccine (adsorbed, reduced
Dextropropoxyphene hydrochloride.................................... 2510 antigen(s) content) ............................................................... 1031
Dextrose.......................................................................... 11.1-4693 Diphtheria, tetanus, pertussis (acellular, component),
Dextrose monohydrate.................................................. 11.1-4694 hepatitis B (rDNA), poliomyelitis (inactivated) and
Diacerein.................................................................................. 2511 haemophilus type b conjugate vaccine (adsorbed) .......... 1033
Diazepam................................................................................. 2513 Diphtheria, tetanus, pertussis (acellular, component),
Diazoxide ................................................................................. 2514 poliomyelitis (inactivated) and haemophilus type b conjugate
Dibrompropamidine diisetionate ......................................... 2515 vaccine (adsorbed) ............................................................... 1035
Dibutyl phthalate .................................................................... 2516 Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis
Dichlorobenzyl alcohol, 2,4- ................................................. 2517 (inactivated) vaccine (adsorbed) ........................................ 1037
Dichloromethane .................................................................... 3382 Diphtheria vaccine (adsorbed).............................................. 1041
Diclazuril for veterinary use......................................... 11.1-4664 Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 285
Diclofenac potassium ............................................................. 2520 Diphtheria vaccine (adsorbed, reduced antigen content).. 1042
Diclofenac sodium.................................................................. 2521 Dipivefrine hydrochloride ..................................................... 2565
Dicloxacillin sodium .............................................................. 2523 Dipotassium clorazepate monohydrate ............................... 2566
Dicyclomine hydrochloride................................................... 2524 Dipotassium disulfite ............................................................. 3767
Dicycloverine hydrochloride................................................. 2524 Dipotassium phosphate ......................................................... 2568
Didanosine .............................................................................. 2525 Diprophylline .......................................................................... 2568
Dienogest ................................................................................. 2527 Dipyridamole .......................................................................... 2569
Diethyl phthalate .................................................................... 2529 Direct amperometric and pulsed electrochemical detection
Diethylcarbamazine citrate.................................................... 2530 (2.2.63.) .................................................................................... 126
Diethylene glycol and ethylene glycol in ethoxylated Dirithromycin ......................................................................... 2571
substances (2.4.30.)................................................................. 173 Disintegration of tablets and capsules (2.9.1.) ...................... 345
Diethylene glycol monoethyl ether ...................................... 2531 Disintegration test for solid rectal and vaginal dosage forms
Diethylene glycol palmitostearate......................................... 2532 (2.9.2.) ...................................................................................... 347
Diffraction, laser light, particle size analysis by (2.9.31.) ... 396 Disodium clodronate tetrahydrate .............................. 11.2-4881
Difloxacin hydrochloride trihydrate for veterinary use..... 2534 Disodium edetate.................................................................... 2573
Digitalis for homoeopathic preparations............................. 1825 Disodium etidronate .............................................................. 2723
Digitalis leaf............................................................................. 1487 Disodium pamidronate pentahydrate .................................. 3626
Digitoxin .................................................................................. 2536 Disodium phosphate .............................................................. 2574
Digoxin .................................................................................... 2537 Disodium phosphate dihydrate............................................. 2574
Dihydralazine sulfate, hydrated ............................................ 2540 Disodium phosphate dodecahydrate.................................... 2575
Dihydrocodeine hydrogen tartrate ....................................... 2541 Disopyramide.......................................................................... 2575
Dihydroergocristine mesilate ................................................ 2542 Disopyramide phosphate ....................................................... 2576
Dihydroergotamine mesilate................................................. 2545 Dispersible tablets................................................................... 1006
Dihydrostreptomycin sulfate for veterinary use ................. 2547 Dissolution, apparent (2.9.43.)................................................ 426

Dissolution, intrinsic (2.9.29.) ................................................ 395 Ear preparations, semi-solid ................................................... 969
Dissolution test for lipophilic solid dosage forms (2.9.42.).. 424 Ear sprays................................................................................... 968
Dissolution test for medicated chewing gums (2.9.25.)....... 387 Ear tampons .............................................................................. 970
Dissolution test for patches (2.9.4.)........................................ 355 Ear washes ................................................................................. 970
Dissolution test for solid dosage forms (2.9.3.) .................... 348 Ebastine.................................................................................... 2621
Dissolution testing, recommendations on (5.17.1.) ............. 837 Eclipta herb ............................................................................. 1495
Distemper vaccine (live), canine........................................... 1145 Econazole................................................................................. 2622
Distemper vaccine (live) for mustelids ................................ 1160 Econazole nitrate .................................................................... 2623
Distillation range (2.2.11.)......................................................... 36 Edetate (chromium (51Cr)) injection.................................... 1251
Distribution estimation by analytical sieving, particle-size Edetate, disodium ................................................................... 2573
(2.9.38.) ......................................................................... 11.1-4523 Edetate, sodium calcium........................................................ 3978
Disulfiram................................................................................ 2577 Edetic acid ............................................................................... 2624
Dithranol ................................................................................. 2578 Edotreotide (gallium (68Ga)) injection................................. 1274
DL-Lysine acetylsalicylate....................................................... 3270 Edrophonium chloride........................................................... 2625
DL-Methionine ........................................................................ 3370 Effervescent granules ............................................................... 973
DL-α-Tocopheryl hydrogen succinate................................... 4242 Effervescent powders ............................................................... 992
DNA, residual host-cell, quantification and characterisation of Effervescent tablets................................................................. 1005
Efficacy of antimicrobial preservation (5.1.3.)...................... 655
(2.6.35.) .................................................................................... 260
Dobesilate monohydrate, calcium ........................................ 2168 Efficacy of veterinary vaccines and immunosera, evaluation of
Dobutamine hydrochloride ................................................... 2579 (5.2.7.) ...................................................................................... 697
Docetaxel ................................................................................. 2581 Egg drop syndrome ‘76 vaccine (inactivated) ..................... 1163
Docetaxel trihydrate ............................................................... 2583 Egg phospholipids for injection............................................ 2626
Docusate sodium .................................................................... 2584 Elder flower ............................................................................. 1496
Dodecyl gallate........................................................................ 2585 Electrochemical detection, pulsed, and direct amperometric
Dog rose................................................................................... 1490 detection (2.2.63.)................................................................... 126
Domperidone .......................................................................... 2586 Electrophoresis (2.2.31.) ............................................................ 57
Domperidone maleate............................................................ 2587 Electrophoresis, capillary (2.2.47.) ........................................... 96
Donepezil hydrochloride ....................................................... 2589 Elemental impurities (5.20.).................................................... 857
Donepezil hydrochloride monohydrate............................... 2590 Elemental impurities, determination of (2.4.20.) ................. 154
Dopamine hydrochloride ...................................................... 2591 Eleutherococcus...................................................................... 1498
Dopexamine dihydrochloride ............................................... 2592 Emedastine difumarate .......................................................... 2628
Dorzolamide hydrochloride .................................................. 2594 Empty sterile containers of plasticised poly(vinyl chloride) for
Dosage forms (glossary) .......................................................... 965 human blood and blood components (3.3.5.)..................... 499
Dosage units, demonstration of uniformity using large sample Emulsifying cetostearyl alcohol (type A)............................. 2276
sizes (2.9.47.) ........................................................................... 432 Emulsifying cetostearyl alcohol (type B) ............................. 2277
Dosage units, uniformity of (2.9.40.) ..................................... 421 Emulsions, intravesical............................................................. 977
Dosulepin hydrochloride....................................................... 2596 Emulsions, oromucosal ............................................................ 986
DOTATOC (gallium (68Ga)) injection ................................. 1274 Emulsions, rectal..................................................................... 1001
Doxapram hydrochloride ...................................................... 2597 Emulsions, solutions and suspensions, oral .......................... 981
Doxazosin mesilate................................................................. 2598 Emulsions, vaginal......................................................... 11.1-4594
Doxepin hydrochloride .......................................................... 2600 Enalapril maleate .................................................................... 2629
Doxorubicin hydrochloride................................................... 2601 Enalaprilat dihydrate.............................................................. 2631
Doxycycline hyclate ................................................................ 2602 Encephalitis vaccine (inactivated), tick-borne.................... 1107
Doxycycline monohydrate..................................................... 2604 Encephalomyelitis vaccine (live), infectious, avian ... 11.1-4600
Doxylamine hydrogen succinate........................................... 2606 Endotoxins, bacterial (2.6.14.) ................................................ 226
Dronedarone hydrochloride.................................................. 2607 Endotoxins, bacterial, guidelines for using the test for
Dronedarone tablets ............................................................... 2608 (5.1.10.) .................................................................................... 669
Drop point (2.2.17.).................................................................... 39 Endotoxins (bacterial) using recombinant factor C, test for
Droperidol ............................................................................... 2610 (2.6.32.) .................................................................................... 252
Droppers (2.1.1.)......................................................................... 17 Enilconazole for veterinary use ............................................ 2632
Drops, ear .................................................................................. 968 Enoxaparin sodium ................................................................ 2634
Drops, eye .................................................................................. 970 Enoxolone ....................................................................... 11.1-4669
Drops, nasal............................................................................... 982 Enrofloxacin for veterinary use............................................. 2637
Drops, oral................................................................................. 981 Entacapone .............................................................................. 2638
Drops, oromucosal ................................................................... 986 Entecavir monohydrate.......................................................... 2640
Drospirenone .......................................................................... 2611 Enteric redmouth disease vaccine (inactivated) for rainbow
Dry extracts ............................................................................... 926 trout........................................................................................ 1164
Dry residue of extracts (2.8.16.).............................................. 327 Enumeration of microbial contaminants in live biotherapeutic
Drying, loss on (2.2.32.)............................................................. 63 products (2.6.36.).................................................................... 262
Drynaria rhizome ................................................................... 1492 Enzootic pneumonia vaccine (inactivated), porcine.......... 1203
Duck plague vaccine (live)..................................................... 1161 Ephedra herb ........................................................................... 1500
Duck viral hepatitis type I vaccine (live) .................... 11.1-4604 Ephedra vulgaris for homoeopathic preparations .............. 1826
Duloxetine hydrochloride...................................................... 2613 Ephedrine ................................................................................ 2642
Dutasteride .............................................................................. 2615 Ephedrine hemihydrate ......................................................... 2642
Dwarf lilyturf tuber ................................................................ 1493 Ephedrine hydrochloride....................................................... 2643
Dwarf pine oil ......................................................................... 1494 Ephedrine hydrochloride, racemic ....................................... 2644
Dydrogesterone....................................................................... 2617 Epinastine hydrochloride....................................................... 2645
Epinephrine ............................................................................. 1886
E Epinephrine tartrate ............................................................... 1887
Ear drops.................................................................................... 968 Epirubicin hydrochloride ...................................................... 2646
Ear powders............................................................................... 970 Eplerenone............................................................................... 2648
Ear preparations........................................................................ 968 Eptacog alfa (activated) concentrated solution................... 2978
Equine herpesvirus vaccine (inactivated)............................ 1166
Equine influenza vaccine (inactivated) ................................ 1167 Etofenamate............................................................................. 2727

Equisetum stem ...................................................................... 1501 Etomidate................................................................................. 2729
Ergocalciferol .......................................................................... 2649 Etoposide ................................................................................. 2730
Ergoloid mesilates................................................................... 2411 Eucalyptus leaf ........................................................................ 1503
Ergometrine maleate .............................................................. 2651 Eucalyptus oil .......................................................................... 1504
Ergotamine tartrate ................................................................ 2653 Eucommia bark....................................................................... 1505
Erysipelas vaccine (inactivated), swine................................ 1221 Eugenol .................................................................................... 2733
Erythritol ................................................................................. 2655 European goldenrod...................................................... 11.2-4856
Erythromycin .......................................................................... 2656 European viper venom antiserum ........................................ 1238
Erythromycin estolate ............................................................ 2660 Evaluation of efficacy of veterinary vaccines and immunosera
Erythromycin ethylsuccinate................................................. 2663 (5.2.7.) ...................................................................................... 697
Erythromycin lactobionate ........................................... 11.1-4670 Evaluation of safety of each batch of immunosera for
Erythromycin stearate............................................................ 2669 veterinary use (5.2.9.)............................................................. 710
Erythropoietin concentrated solution.................................. 2672 Evaluation of safety of veterinary vaccines and immunosera
Escitalopram............................................................................ 2677 (5.2.6.) ...................................................................................... 695
Escitalopram oxalate .............................................................. 2679 Evening primrose oil, refined................................................ 2735
Eserine salicylate..................................................................... 3711 Everolimus ...................................................................... 11.1-4680
Esketamine hydrochloride..................................................... 2681 Evodia fruit.............................................................................. 1506
Esomeprazole magnesium dihydrate ................................... 2682 Excipients, functionality-related characteristics of (5.15.) .. 829
Esomeprazole magnesium trihydrate................................... 2684 Exemestane.............................................................................. 2738
Esomeprazole sodium ............................................................ 2686 Extemporaneous preparation of radiopharmaceuticals
Essential oils .............................................................................. 922 (5.19.) ....................................................................................... 849
Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 323 Extractable volume of parenteral preparations, test for
Essential oils, fatty oils and resinified essential oils in (2.9.17.) .................................................................................... 369
(2.8.7.) ...................................................................................... 322 Extracts, dry .............................................................................. 926
Essential oils, foreign esters in (2.8.6.)................................... 322 Extracts, dry residue of (2.8.16.)............................................. 327
Essential oils in herbal drugs (2.8.12.) ................................... 323 Extracts, herbal drug ................................................................ 924
Essential oils, monographs on (information chapter) Extracts, herbal drug, monographs on (information chapter)
(5.30.) ....................................................................................... 915 (5.23.) ....................................................................................... 885
Essential oils, odour and taste (2.8.8.) ................................... 322 Extracts, liquid (fluid) .............................................................. 925
Essential oils, residue on evaporation (2.8.9.)....................... 322 Extracts, loss on drying of (2.8.17.)........................................ 327
Essential oils, solubility in alcohol (2.8.10.) .......................... 323 Extracts, soft.............................................................................. 926
Essential oils, water in (2.8.5.)................................................. 322 Extracts used in the preparation of herbal medicinal products
Ester value (2.5.2.) .................................................................... 179 for oral use, microbiological examination (2.6.31.) ........... 249
Estradiol benzoate .................................................................. 2688 Extracts used in the preparation of herbal medicinal products
Estradiol hemihydrate............................................................ 2689 for oral use, microbiological quality (5.1.8.) ....................... 668
Estradiol valerate .................................................................... 2690 Extracts, water for preparation of......................................... 4390
Estriol .............................................................................. 11.1-4673 Extraneous agents in viral vaccines for human use, tests for
Estrogens, conjugated............................................................. 2694 (2.6.16.) .................................................................................... 230
Etacrynic acid.......................................................................... 2696 Extraneous viruses in immunological veterinary medicinal
Etamsylate................................................................................ 2698 products - principles for the detection of, using culture
Etanercept ....................................................................... 11.1-4675 methods (2.6.37.).................................................................... 267
Ethacridine lactate monohydrate.......................................... 2703 Eye drops ................................................................................... 970
Ethambutol hydrochloride .................................................... 2704 Eye drops, powders for............................................................. 970
Ethanol (96 per cent).............................................................. 2706 Eye lotions ................................................................................. 971
Ethanol, anhydrous................................................................. 2708 Eye lotions, powders for........................................................... 970
Ethanol content (2.9.10.) ......................................................... 362 Eye preparations ....................................................................... 970
Ethanolamine .......................................................................... 2710 Eye preparations, semi-solid ................................................... 971
Ether ................................................................................ 11.2-4891
Ethinylestradiol....................................................................... 2712 F
Ethionamide ............................................................................ 2714 F concepts to the heat sterilisation processes, application of
Ethosuximide .......................................................................... 2715 (5.1.5.) ...................................................................................... 658
Ethoxylated substances, ethylene glycol and diethylene glycol Factor II, human coagulation, assay of (2.7.18.) ................... 303
in (2.4.30.) ............................................................................... 173 Factor IX, human coagulation .............................................. 2985
Ethyl acetate ............................................................................ 2716 Factor IX, human coagulation, assay of (2.7.11.).................. 297
Ethyl acrylate - methacrylic acid copolymer (1:1).............. 3360 Factor IX (rDNA) concentrated solution, human
Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion coagulation ............................................................................ 2986
30 per cent ............................................................................. 3361 Factor IX (rDNA) powder for solution for injection, human
Ethyl oleate .............................................................................. 2717 coagulation ............................................................................ 2991
Ethyl parahydroxybenzoate ................................................... 2717 Factor VII, human coagulation............................................. 2977
Ethyl parahydroxybenzoate sodium..................................... 3988 Factor VII, human coagulation, assay of (2.7.10.)................ 296
Ethylcellulose........................................................................... 2718 Factor VIIa (rDNA) concentrated solution, human coagulation
Ethylene glycol and diethylene glycol in ethoxylated substances ................................................................................................ 2978
(2.4.30.) .................................................................................... 173 Factor VIII, human coagulation ........................................... 2983
Ethylene glycol monopalmitostearate .................................. 2720 Factor VIII, human coagulation, assay of (2.7.4.) ................ 284
Ethylene glycol monostearate................................................ 2720 Factor VIII (rDNA), human coagulation ............................ 2984
Ethylene oxide and dioxan (2.4.25.) ....................................... 167 Factor X, human coagulation, assay of (2.7.19.) ................... 304
Ethylenediamine ..................................................................... 2721 Factor XI, human coagulation .............................................. 2994
Ethylhexanoic acid, 2- (2.4.28.)............................................... 170 Factor XI, human coagulation, assay of (2.7.22.) ................. 307
Ethylmorphine hydrochloride............................................... 2721 Falling ball and automatic rolling ball viscometer methods
Etidronate disodium............................................................... 2723 (2.2.49.) .................................................................................... 104
Etilefrine hydrochloride......................................................... 2723 Famotidine............................................................................... 2743
Etodolac ................................................................................... 2725

Fat, hard ................................................................................... 2949 Flucloxacillin sodium monohydrate..................................... 2781

Fat, hard with additives.......................................................... 2950 Fluconazole.............................................................................. 2783
Fatty acids, composition by gas chromatography (2.4.22.).. 157 Flucytosine............................................................................... 2785
Fatty acids in oils rich in omega-3 acids, composition of Fludarabine phosphate........................................................... 2786
(2.4.29.) .................................................................................... 171 Fludeoxyglucose (18F) injection ............................................ 1255
Fatty oils, alkaline impurities in (2.4.19.) .............................. 154 Fludrocortisone acetate.......................................................... 2788
Fatty oils and resinified essential oils in essential oils Flumazenil ............................................................................... 2790
(2.8.7.) ...................................................................................... 322 Flumazenil (N-[11C]methyl) injection......................... 11.1-4615
Fatty oils, foreign oils in, by thin-layer chromatography Flumequine.............................................................................. 2791
(2.4.21.) .................................................................................... 157 Flumetasone pivalate.............................................................. 2792
Fatty oils, identification by thin-layer chromatography Flunarizine dihydrochloride......................................... 11.2-4895
(2.3.2.) ...................................................................................... 142 Flunitrazepam ......................................................................... 2795
Fatty oils, sterols in (2.4.23.).................................................... 160 Flunixin meglumine for veterinary use ............................... 2796
Fatty oils, vegetable................................................................... 960 Fluocinolone acetonide.......................................................... 2797
Fc function of immunoglobulin, test for (2.7.9.).................. 295 Fluocortolone pivalate............................................................ 2799
Febantel for veterinary use .................................................... 2744 Fluorescein .............................................................................. 2801
Feeding stuffs for veterinary use, medicated, premixes for.. 993 Fluorescein sodium ................................................................ 2802
Felbinac .................................................................................... 2745 Fluoride (18F) solution for radiolabelling............................. 1259
Feline calicivirosis vaccine (inactivated).............................. 1169 Fluorides (2.4.5.)....................................................................... 148
Feline calicivirosis vaccine (live)........................................... 1170 Fluorimetry (2.2.21.) .................................................................. 41
Feline chlamydiosis vaccine (inactivated) ........................... 1171 Fluorocholine (18F) injection................................................. 1260
Feline infectious enteritis (feline panleucopenia) vaccine Fluorodeoxythymidine (18F) injection ................................. 1245
(inactivated) .......................................................................... 1172 Fluorodopa (18F) (prepared by electrophilic substitution)
Feline infectious enteritis (feline panleucopenia) vaccine injection ................................................................................. 1262
(live) ....................................................................................... 1173 Fluorodopa (18F) (prepared by nucleophilic substitution)
Feline leukaemia vaccine (inactivated) ................................ 1175 injection ................................................................................. 1263
Feline panleucopenia vaccine (inactivated)......................... 1172 Fluoroethyl-L-tyrosine (18F) injection .................................. 1266
Feline panleucopenia vaccine (live) ..................................... 1173 Fluoromisonidazole (18F) injection....................................... 1269
Feline viral rhinotracheitis vaccine (inactivated) ............... 1176 Fluorouracil ............................................................................. 2804
Feline viral rhinotracheitis vaccine (live) ............................ 1177 Fluoxetine hydrochloride....................................................... 2805
Felodipine ....................................................................... 11.1-4685 Flupentixol dihydrochloride.................................................. 2806
Felypressin ............................................................................... 2748 Fluphenazine decanoate......................................................... 2809
Fenbendazole for veterinary use........................................... 2749 Fluphenazine dihydrochloride .............................................. 2810
Fenbufen .................................................................................. 2750 Fluphenazine enantate ........................................................... 2812
Fennel, bitter ........................................................................... 1508 Flurazepam monohydrochloride .......................................... 2814
Fennel, sweet ........................................................................... 1509 Flurbiprofen............................................................................. 2815
Fenofibrate............................................................................... 2751 Fluspirilene .............................................................................. 2816
Fenoterol hydrobromide ........................................................ 2752 Flutamide................................................................................. 2817
Fentanyl.................................................................................... 2753 Fluticasone furoate ................................................................. 2818
Fentanyl citrate........................................................................ 2755 Fluticasone propionate........................................................... 2820
Fenticonazole nitrate .............................................................. 2756 Flutrimazole ............................................................................ 2823
Fenugreek ................................................................................ 1510 Fluvastatin sodium ................................................................. 2824
Fermentation, products of ....................................................... 941 Fluvoxamine maleate.............................................................. 2826
Ferric chloride hexahydrate................................................... 2758 FMISO (18F) injection ............................................................ 1269
Ferrous fumarate..................................................................... 2758 Foam index (2.8.24.)................................................................. 333
Ferrous gluconate hydrate ..................................................... 2759 Foams, cutaneous ..................................................................... 980
Ferrous sulfate, dried.............................................................. 2760 Foams, intrauterine .................................................................. 975
Ferrous sulfate heptahydrate ................................................. 2761 Foams, medicated ..................................................................... 972
Ferrum metallicum for homoeopathic preparations ......... 1828 Foams, rectal ........................................................................... 1001
FET (18F) injection.................................................................. 1266 Foams, vaginal................................................................ 11.1-4594
Feverfew ................................................................................... 1511 Folic acid hydrate.................................................................... 2827
Fexofenadine hydrochloride.................................................. 2762 Folinate hydrate, calcium....................................................... 2169
Fibrin sealant kit ..................................................................... 2763 Follitropin ................................................................................ 2829
Fibrinogen, human ................................................................. 2995 Follitropin concentrated solution ......................................... 2835
Filgrastim concentrated solution.......................................... 2765 Foot-and-mouth disease (ruminants) vaccine
Filgrastim injection ................................................................ 2767 (inactivated) .......................................................................... 1178
Films, buccal.............................................................................. 987 Foreign esters in essential oils (2.8.6.).................................... 322
Films, orodispersible ................................................................ 987 Foreign matter (2.8.2.) .................................................. 11.1-4519
Finasteride ............................................................................... 2769 Foreign oils in fatty oils by thin-layer chromatography
Fineness, powder (2.9.35.) ....................................................... 410 (2.4.21.) .................................................................................... 157
Fingolimod hydrochloride..................................................... 2771 Formaldehyde, free (2.4.18.).................................................... 153
Fipronil for veterinary use..................................................... 2772 Formaldehyde solution (35 per cent) ................................... 2840
Fish oil, rich in omega-3 acids .............................................. 2773 Formic acid.............................................................................. 2841
Flavoxate hydrochloride......................................................... 2775 Formoterol fumarate dihydrate............................................. 2842
Flecainide acetate.................................................................... 2776 Forsythia fruit ......................................................................... 1514
Fleeceflower root..................................................................... 1512 Foscarnet sodium hexahydrate ............................................. 2844
Flocculation value (Lf) of diphtheria and tetanus toxins and Fosfomycin calcium................................................................ 2845
toxoids (Ramon assay) (2.7.27.)............................................ 310 Fosfomycin sodium ................................................................ 2846
Flow cytometry (2.7.24.).......................................................... 308 Fosfomycin trometamol......................................................... 2847
Flowability (2.9.16.).................................................................. 368 Fosinopril sodium .................................................................. 2849
FLT (18F) injection .................................................................. 1245 Fourstamen stephania root.................................................... 1515
Flubendazole ........................................................................... 2778 Fowl cholera vaccine (inactivated) ....................................... 1180
Flucloxacillin magnesium octahydrate ................................ 2779 Fowl-pox vaccine (live) ................................................. 11.1-4605
Framycetin sulfate .................................................................. 2851 General notices (1.) ...................................................................... 3

Frangula bark .......................................................................... 1516 General texts on biological products (5.2.) ........................... 679
Frangula bark dry extract, standardised .............................. 1518 General texts on microbiology (5.1.) ..................................... 649
Frankincense, Indian.............................................................. 1562 Genetically modified cells........................................................ 815
Fraxinus chinensis bark ......................................................... 1518 Gentamicin sulfate.................................................................. 2880
Free formaldehyde (2.4.18.)..................................................... 153 Gentian root ............................................................................ 1527
Freezing point (2.2.18.) .............................................................. 40 Gentian tincture...................................................................... 1528
Fresh bilberry fruit dry extract, refined and standardised.. 1520 Gestodene ................................................................................ 2882
Friability of granules and spheroids (2.9.41.)........................ 423 Ginger ...................................................................................... 1529
Friability of uncoated tablets (2.9.7.) ..................................... 359 Gingival preparations............................................................... 985
Fructose........................................................................... 11.1-4686 Ginkgo dry extract, refined and quantified ......................... 1530
Fucus ........................................................................................ 1576 Ginkgo leaf .............................................................................. 1533
Fulvestrant ...................................................................... 11.1-4687 Ginseng .................................................................................... 1534
Fulvestrant injection...................................................... 11.1-4689 Ginseng dry extract ................................................................ 1536
Fumitory .................................................................................. 1522 Glass containers for pharmaceutical use (3.2.1.) .................. 479
Functional groups and ions, identification reactions of Glibenclamide ......................................................................... 2884
(2.3.1.) ...................................................................................... 139 Gliclazide ................................................................................. 2886
Functionality-related characteristics of excipients (5.15.) ... 829 Glimepiride ............................................................................. 2887
Fungicidal, bactericidal or yeasticidal activity of antiseptic Glipizide................................................................................... 2889
medicinal products, determination of (5.1.11.) .................. 673 Glossary ..................................................................................... 965
Furosemide .............................................................................. 2855 Glossary (dosage forms) .......................................................... 965
Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) Glucagon, human ................................................................... 2891
for salmonids......................................................................... 1182 Glucoheptonate, calcium ....................................................... 2171
Fusidate, sodium..................................................................... 3990 Glucosamine hydrochloride .................................................. 2892
Fusidic acid.............................................................................. 2857 Glucosamine sulfate potassium chloride ............................. 2893
Glucosamine sulfate sodium chloride.................................. 2895
G Glucose............................................................................ 11.1-4693
Gabapentin .............................................................................. 2863 Glucose, liquid ........................................................................ 2898
Gadobutrol monohydrate ...................................................... 2864 Glucose, liquid, spray-dried .................................................. 2898
Gadodiamide hydrate............................................................. 2866 Glucose monohydrate ................................................... 11.1-4694
Galactose.................................................................................. 2868 Glutamic acid .......................................................................... 2901
Galantamine hydrobromide .................................................. 2869 Glutathione.............................................................................. 2902
Gallium (67Ga) citrate injection ............................................ 1271 Glycan analysis of glycoproteins (2.2.59.) ............................. 119
Gallium (68Ga) chloride (accelerator-produced) solution for Glycerol.................................................................................... 2903
radiolabelling ............................................................... 11.1-4616 Glycerol (85 per cent)............................................................. 2905
Gallium (68Ga) chloride solution for radiolabelling ........... 1273 Glycerol dibehenate................................................................ 2906
Gallium (68Ga) DOTATOC injection ................................... 1274 Glycerol distearate .................................................................. 2907
Gallium (68Ga) edotreotide injection ................................... 1274 Glycerol formal ....................................................................... 2908
Gallium (68Ga) PSMA-11 injection ...................................... 1276 Glycerol monocaprylate......................................................... 2908
Gammacyclodextrin ............................................................... 2872 Glycerol monocaprylocaprate ............................................... 2909
Gammadex .............................................................................. 2872 Glycerol monolinoleate.......................................................... 2910
Ganciclovir .............................................................................. 2873 Glycerol mono-oleate ............................................................. 2911
Ganoderma.............................................................................. 1523 Glycerol monostearate 40-55 ................................................ 2912
Gargles ....................................................................................... 985 Glycerol triacetate................................................................... 4265
Garlic for homoeopathic preparations................................. 1811 Glyceryl trinitrate solution .................................................... 2914
Garlic powder.......................................................................... 1525 Glycine ..................................................................................... 2915
Gas adsorption, specific surface area by (2.9.26.)................. 392 Glycoproteins, glycan analysis of (2.2.59.) ............................ 119
Gas chromatography (2.2.28.)...................................... 11.1-4502 Glycopyrronium bromide...................................................... 2917
Gas detector tubes (2.1.6.) ......................................................... 19 Glycyrrhetinic acid ........................................................ 11.1-4669
Gas pycnometric density of solids (2.9.23.)........................... 386 Glycyrrhizate ammonium...................................................... 1953
Gases, carbon dioxide in (2.5.24.) .......................................... 186 Goldenrod....................................................................... 11.2-4855
Gases, carbon monoxide in (2.5.25.)...................................... 187 Goldenrod, European.................................................... 11.2-4856
Gases, nitrogen monoxide and nitrogen dioxide in Goldenseal rhizome................................................................ 1540
(2.5.26.) .................................................................................... 188 Gonadorelin acetate................................................................ 2919
Gases, nitrous oxide in (2.5.35.) ............................................. 194 Gonadotrophin, chorionic..................................................... 2920
Gases, oxygen in (2.5.27.) ........................................................ 188 Goserelin.................................................................................. 2921
Gases, water in (2.5.28.)........................................................... 188 Grafted copolymer, macrogol poly(vinyl alcohol) ............. 3284
Gas-gangrene antitoxin, mixed ............................................. 1234 Gramicidin .............................................................................. 2923
Gas-gangrene antitoxin (novyi) ............................................ 1235 Granisetron hydrochloride.................................................... 2924
Gas-gangrene antitoxin (perfringens).................................. 1235 Granules..................................................................................... 973
Gas-gangrene antitoxin (septicum)...................................... 1236 Granules and powders for oral solutions and suspensions.. 981
Gastrodia rhizome .................................................................. 1526 Granules and powders for syrups ........................................... 981
Gastro-resistant capsules ......................................................... 967 Granules and spheroids, friability of (2.9.41.)....................... 423
Gastro-resistant granules ......................................................... 974 Granules, coated ....................................................................... 974
Gastro-resistant tablets .......................................................... 1005 Granules, effervescent .............................................................. 973
Gefitinib ................................................................................... 2875 Granules, gastro-resistant ........................................................ 974
Gelatin...................................................................................... 2876 Granules, modified-release...................................................... 974
Gels........................................................................................... 1003 Greater celandine........................................................... 11.1-4626
Gels for injection ...................................................................... 990 Green tea.................................................................................. 1543
Gemcitabine hydrochloride................................................... 2877 Griseofulvin............................................................................. 2926
Gemfibrozil.............................................................................. 2878 Guaiacol ................................................................................... 2927
Gene transfer medicinal products for human use (5.14.).... 815 Guaifenesin.............................................................................. 2929
Guanethidine monosulfate .................................................... 2931

Guar.......................................................................................... 1545 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine

Guar galactomannan .............................................................. 2931 (adsorbed) ............................................................................. 1047
Guarana.................................................................................... 1546 Hepatitis A vaccine, assay of (2.7.14.) .................................... 300
Guidelines for using the test for bacterial endotoxins Hepatitis A vaccine (inactivated, adsorbed)........................ 1048
(5.1.10.) .................................................................................... 669 Hepatitis A vaccine (inactivated, virosome)........................ 1050
Guidelines for using the test for sterility (5.1.9.) .................. 669 Hepatitis B immunoglobulin for intravenous administration,
human .................................................................................... 2997
H Hepatitis B immunoglobulin, human .................................. 2997
Haemagglutinins, anti-A and anti-B (2.6.20.)....................... 235 Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,
Haematopoietic products, numeration of CD34/CD45+ cells component), poliomyelitis (inactivated) and haemophilus
in (2.7.23.) ............................................................................... 307 type b conjugate vaccine (adsorbed) .................................. 1033
Haematopoietic progenitor cells, human, colony-forming cell Hepatitis B vaccine (rDNA) .................................................. 1052
assay for (2.7.28.) .................................................................... 311 Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 300
Haematopoietic stem cells, human....................................... 2995 Hepatitis C virus (HCV), validation of nucleic acid
Haemodiafiltration and haemofiltration, concentrated amplification techniques for the detection of HCV RNA in
solutions for........................................................................... 2939 plasma pools : guidelines ....................................................... 236
Haemodiafiltration and haemofiltration, solutions for...... 2941 Hepatitis type I vaccine (live), viral, duck .................. 11.1-4604
Haemodialysis, concentrated solutions for ......................... 2936 Heptaminol hydrochloride .................................................... 2959
Haemodialysis solutions, concentrated, water for Herbal drug extracts................................................................. 924
diluting................................................................................... 2935 Herbal drug extracts, monographs on (information chapter)
Haemodialysis, solutions for ................................................. 2936 (5.23.) ....................................................................................... 885
Haemofiltration and haemodiafiltration, concentrated Herbal drug preparations ........................................................ 927
solutions for........................................................................... 2939 Herbal drugs.............................................................................. 927
Haemofiltration and haemodiafiltration, solutions for...... 2941 Herbal drugs and herbal drug preparations, heavy metals in
Haemophilus type b and meningococcal group C conjugate (2.4.27.) .................................................................................... 168
vaccine ................................................................................... 1043 Herbal drugs and herbal drug preparations, high-performance
Haemophilus type b (conjugate), diphtheria, tetanus and thin-layer chromatography of (2.8.25.)................................ 334
pertussis (acellular, component) vaccine (adsorbed)....... 1026 Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 327
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis Herbal drugs, essential oils in (2.8.12.).................................. 323
(acellular, component) and poliomyelitis (inactivated) Herbal drugs for homoeopathic preparations..................... 1788
vaccine (adsorbed) ............................................................... 1035 Herbal drugs : introduction ................................................... 1357
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis Herbal drugs, microscopic examination of (2.8.23)............. 333
(acellular, component), hepatitis B (rDNA) and poliomyelitis Herbal drugs : sampling and sample preparation (2.8.20.).. 329
(inactivated) vaccine (adsorbed) ........................................ 1033 Herbal drugs, tannins in (2.8.14.)........................................... 326
Haemophilus type b conjugate vaccine................................ 1044 Herbal drugs, test for aristolochic acids in (2.8.21) ............. 330
Haemorrhagic disease vaccine (inactivated), rabbit........... 1209 Herbal medicinal products for oral use and extracts used in
Halofantrine hydrochloride................................................... 2943 their preparation, microbiological examination (2.6.31.).. 249
Haloperidol.............................................................................. 2944 Herbal medicinal products for oral use and extracts used in
Haloperidol decanoate ........................................................... 2946 their preparation, microbiological quality (5.1.8.) ............. 668
Halothane ................................................................................ 2948 Herbal preparations.................................................................. 927
Hamamelis bark...................................................................... 1547 Herbal substances ..................................................................... 927
Hamamelis leaf........................................................................ 1548 Herbal teas................................................................................. 929
Hard capsules ............................................................................ 966 Herbal teas, instant................................................................... 929
Hard fat .................................................................................... 2949 Herpes zoster (shingles) vaccine (live)................................. 1100
Hard fat with additives........................................................... 2950 Herpesvirus vaccine (inactivated), equine........................... 1166
Hard paraffin........................................................................... 3635 Hexamidine diisetionate ........................................................ 2960
Harmonisation, pharmacopoeial (5.8.).................................. 791 Hexetidine ............................................................................... 2962
Hawthorn berries.................................................................... 1549 Hexosamines in polysaccharide vaccines (2.5.20.) ............... 185
Hawthorn leaf and flower ...................................................... 1551 Hexylresorcinol ....................................................................... 2963
Hawthorn leaf and flower dry extract .................................. 1553 High-molecular-mass macrogols.......................................... 3291
Hawthorn leaf and flower liquid extract.............................. 1555 High-performance thin-layer chromatography of herbal drugs
HCP assays (2.6.34.) ................................................................. 256 and herbal drug preparations (2.8.25.) ................................ 334
Healthy chicken flocks for the production of inactivated Histamine (2.6.10.) ................................................................... 216
vaccines for veterinary use (5.2.13.)..................................... 715 Histamine dihydrochloride ................................................... 2964
Heat sterilisation, application of the F concepts (5.1.5.)...... 658 Histaminum for homoeopathic preparations ..................... 1829
Heavy bismuth subnitrate...................................................... 2104 Histidine .................................................................................. 2965
Heavy kaolin............................................................................ 3171 Histidine hydrochloride monohydrate ................................ 2966
Heavy magnesium carbonate ................................................ 3297 Homatropine hydrobromide ................................................. 2967
Heavy magnesium oxide........................................................ 3304 Homatropine methylbromide ............................................... 2968
Heavy metals (2.4.8.)................................................................ 149 Homoeopathic pillules, coated.............................................. 1806
Heavy metals in herbal drugs and herbal drug preparations Homoeopathic pillules, impregnated ................................... 1806
(2.4.27.) .................................................................................... 168 Homoeopathic preparations.................................................. 1787
Hedera helix for homoeopathic preparations ..................... 1828 Homoeopathic preparations : introduction ......................... 1787
Helium ..................................................................................... 2952 Homoeopathic stocks (methods of preparation of) and
Heparin, assay of (2.7.5.) ......................................................... 285 potentisation ......................................................................... 1790
Heparin calcium ..................................................................... 2953 Honey ....................................................................................... 2970
Heparin in coagulation factors, assay of (2.7.12.)................. 297 Honey bee for homoeopathic preparations......................... 1814
Heparin sodium ...................................................................... 2955 Hop strobile............................................................................. 1556
Heparins, low-molecular-mass .................................... 11.2-4899 Horse-chestnut........................................................................ 1557
Hepatitis A immunoglobulin, human.................................. 2996 Horse-chestnut dry extract, standardised............................ 1559
Hepatitis A (inactivated, adsorbed) and typhoid polysaccharide Host-cell DNA, residual, quantification and characterisation
vaccine ................................................................................... 1046 of (2.6.35.)................................................................................ 260
Host-cell protein assays (2.6.34.) ............................................ 256
Houttuynia herb...................................................................... 1560 Hydrocortisone hydrogen succinate..................................... 3027

Human α-1-proteinase inhibitor .......................................... 3007 Hydrogen peroxide solution (3 per cent)............................. 3029
Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 315 Hydrogen peroxide solution (30 per cent)........................... 3029
Human albumin injection, iodinated (125I) ......................... 1277 Hydrogenated arachis oil ....................................................... 1989
Human albumin solution ...................................................... 2971 Hydrogenated castor oil......................................................... 2222
Human anti-D immunoglobulin .......................................... 2973 Hydrogenated cottonseed oil................................................. 2435
Human anti-D immunoglobulin, assay of (2.7.13.) ............. 298 Hydrogenated soya-bean oil.................................................. 4047
Human anti-D immunoglobulin for intravenous Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 173
administration....................................................................... 2974 Hydrogenated wool fat........................................................... 4399
Human antithrombin III, assay of (2.7.17.)........................... 303 Hydromorphone hydrochloride............................................ 3030
Human antithrombin III concentrate .................................. 2974 Hydrophobic colloidal silica.................................................. 3961
Human C1-esterase inhibitor................................................ 2976 Hydrous wool fat .................................................................... 4401
Human C1-esterase inhibitor, assay of (2.7.34.) ................... 316 Hydroxocobalamin acetate .................................................... 3031
Human coagulation factor II, assay of (2.7.18.) .................... 303 Hydroxocobalamin chloride.................................................. 3032
Human coagulation factor IX ............................................... 2985 Hydroxocobalamin sulfate..................................................... 3033
Human coagulation factor IX, assay of (2.7.11.)................... 297 Hydroxycarbamide ................................................................. 3034
Human coagulation factor IX (rDNA) concentrated Hydroxychloroquine sulfate .................................................. 3035
solution .................................................................................. 2986 Hydroxyethyl salicylate .......................................................... 3037
Human coagulation factor IX (rDNA) powder for solution for Hydroxyethyl starches ............................................................ 4066
injection ................................................................................. 2991 Hydroxyethylcellulose ............................................................ 3038
Human coagulation factor VII.............................................. 2977 Hydroxyethylmethylcellulose ................................................ 3385
Human coagulation factor VII, assay of (2.7.10.)................. 296 Hydroxyl value (2.5.3.)............................................................. 179
Human coagulation factor VIIa (rDNA) concentrated Hydroxypropyl starch.................................................... 11.2-4957
solution .................................................................................. 2978 Hydroxypropyl starch, pregelatinised ......................... 11.2-4959
Human coagulation factor VIII ............................................ 2983 Hydroxypropylbetadex........................................................... 3041
Human coagulation factor VIII, assay of (2.7.4.) ................. 284 Hydroxypropylcellulose ......................................................... 3043
Human coagulation factor VIII (rDNA) ............................. 2984 Hydroxypropylcellulose, low-substituted ............................ 3045
Human coagulation factor X, assay of (2.7.19.) .................... 304 Hydroxypropylmethylcellulose ............................................. 3055
Human coagulation factor XI ............................................... 2994 Hydroxypropylmethylcellulose phthalate ............................ 3057
Human coagulation factor XI, assay of (2.7.22.) .................. 307 Hydroxyzine hydrochloride................................................... 3046
Human fibrinogen .................................................................. 2995 Hymecromone......................................................................... 3047
Human glucagon..................................................................... 2891 Hymenoptera venoms for allergen products....................... 3048
Human haematopoietic progenitor cells, colony-forming cell Hyoscine .................................................................................. 3049
assay for (2.7.28.) .................................................................... 311 Hyoscine butylbromide.......................................................... 3050
Human haematopoietic stem cells........................................ 2995 Hyoscine hydrobromide ........................................................ 3052
Human hepatitis A immunoglobulin ................................... 2996 Hyoscyamine sulfate............................................................... 3053
Human hepatitis B immunoglobulin ................................... 2997 Hyoscyamus for homoeopathic preparations ..................... 1831
Human hepatitis B immunoglobulin for intravenous Hypericum............................................................................... 1736
administration....................................................................... 2997 Hypericum for homoeopathic preparations........................ 1832
Human insulin ........................................................................ 3090 Hypromellose .......................................................................... 3055
Human measles immunoglobulin ........................................ 2998 Hypromellose phthalate ......................................................... 3057
Human normal immunoglobulin for intramuscular
administration....................................................................... 2998 I
Human normal immunoglobulin for intravenous Ibandronate sodium monohydrate....................................... 3061
administration....................................................................... 3000 Ibuprofen ................................................................................. 3062
Human normal immunoglobulin for subcutaneous Iceland moss............................................................................ 1561
administration....................................................................... 3002 ICH (5.8.)................................................................................... 791
Human papillomavirus vaccine (rDNA) ............................. 1054 Ichthammol ............................................................................. 3064
Human plasma for fractionation .......................................... 3004 Identification (2.3.) ................................................................... 139
Human plasma (pooled and treated for virus Identification and control of residual solvents (2.4.24.) ...... 162
inactivation) .......................................................................... 3005 Identification of fatty oils by thin-layer chromatography
Human plasmin inhibitor, assay of (2.7.25.) ......................... 310 (2.3.2.) ...................................................................................... 142
Human protein C, assay of (2.7.30.)....................................... 314 Identification of phenothiazines by thin-layer chromatography
Human protein S, assay of (2.7.31.)........................................ 315 (2.3.3.) ...................................................................................... 143
Human prothrombin complex .............................................. 3008 Identification reactions of ions and functional groups
Human rabies immunoglobulin ........................................... 3010 (2.3.1.) ...................................................................................... 139
Human rubella immunoglobulin ......................................... 3011 Idoxuridine .............................................................................. 3065
Human tetanus immunoglobulin ......................................... 3011 Ifosfamide ................................................................................ 3066
Human varicella immunoglobulin ....................................... 3013 Ignatia for homoeopathic preparations ............................... 1833
Human varicella immunoglobulin for intravenous Imatinib mesilate .................................................................... 3067
administration....................................................................... 3014 Imidacloprid for veterinary use ............................................ 3070
Human von Willebrand factor .............................................. 3014 Imipenem monohydrate ........................................................ 3071
Human von Willebrand factor, assay of (2.7.21.) ................. 305 Imipramine hydrochloride .................................................... 3072
Hyaluronate, sodium.............................................................. 3993 Immunochemical methods (2.7.1.) ........................................ 277
Hyaluronidase ......................................................................... 3015 Immunoglobulin for human use, anti-T lymphocyte,
Hydralazine hydrochloride.................................................... 3016 animal .................................................................................... 1978
Hydrastis canadensis for homoeopathic preparations ....... 1830 Immunoglobulin for intramuscular administration, human
Hydrochloric acid, concentrated .......................................... 3018 normal.................................................................................... 2998
Hydrochloric acid, dilute ....................................................... 3018 Immunoglobulin for intravenous administration, human
Hydrochlorothiazide .............................................................. 3019 anti-D ..................................................................................... 2974
Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 3020 Immunoglobulin for intravenous administration, human
Hydrocortisone ....................................................................... 3022 hepatitis B .............................................................................. 2997
Hydrocortisone acetate .......................................................... 3025

Immunoglobulin for intravenous administration, human Influenza vaccine (surface antigen, inactivated, prepared in
normal.................................................................................... 3000 cell cultures) .......................................................................... 1062
Immunoglobulin for intravenous administration, human Influenza vaccine (surface antigen, inactivated,
varicella.................................................................................. 3014 virosome)............................................................................... 1064
Immunoglobulin for subcutaneous administration, human Influenza vaccine (whole virion, inactivated) ..................... 1066
normal.................................................................................... 3002 Influenza vaccine (whole virion, inactivated, prepared in cell
Immunoglobulin, human anti-D .......................................... 2973 cultures) ................................................................................. 1068
Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 298 Infrared absorption spectrophotometry (2.2.24.)................... 45
Immunoglobulin, human hepatitis A................................... 2996 Infusions .................................................................................... 989
Immunoglobulin, human hepatitis B ................................... 2997 Inhalation gas, krypton (81mKr)............................................. 1285
Immunoglobulin, human measles ........................................ 2998 Inhalation powders................................................................... 997
Immunoglobulin, human rabies ........................................... 3010 Inhalation, preparations for .................................................... 993
Immunoglobulin, human rubella ......................................... 3011 Inhalation, preparations for : aerodynamic assessment of fine
Immunoglobulin, human tetanus......................................... 3011 particles (2.9.18.) .................................................................... 369
Immunoglobulin, human varicella....................................... 3013 Injectable insulin preparations.............................................. 3098
Immunoglobulin, test for anticomplementary activity of Injection, gels for ...................................................................... 990
(2.6.17.) ......................................................................... 11.1-4509 Injections ................................................................................... 989
Immunoglobulin, test for Fc function of (2.7.9.).................. 295 Injections or infusions, concentrates for ............................... 989
Immunonephelometry for vaccine component assay Injections or infusions, powders for....................................... 989
(2.7.35.) .................................................................................... 316 Injections, water for....................................................... 11.1-4773
Immunosera and vaccines, phenol in (2.5.15.) ..................... 184 Inositol, myo- .......................................................................... 3085
Immunosera and vaccines, veterinary, evaluation of efficacy Inserts, ophthalmic................................................................... 972
of (5.2.7.).................................................................................. 697 Instant herbal teas .................................................................... 929
Immunosera and vaccines, veterinary, evaluation of safety Insulin aspart........................................................................... 3086
(5.2.6.) ...................................................................................... 695 Insulin glargine ....................................................................... 3088
Immunosera for human use, animal ...................................... 929 Insulin, human........................................................................ 3090
Immunosera for veterinary use............................................... 932 Insulin injection, biphasic isophane..................................... 3092
Immunosera for veterinary use, evaluation of the safety of Insulin injection, isophane .................................................... 3093
each batch (5.2.9.)................................................................... 710 Insulin injection, soluble ....................................................... 3093
Implants ..................................................................................... 990 Insulin lispro ........................................................................... 3093
Implementation of pharmacopoeial procedures (5.26.) ...... 903 Insulin, porcine ....................................................................... 3096
Impurities, elemental, determination of (2.4.20.)................. 154 Insulin preparations, injectable............................................. 3098
Impurities in substances for pharmaceutical use, control of Insulin zinc injectable suspension ........................................ 3100
(5.10.) ....................................................................................... 799 Insulin zinc injectable suspension (amorphous) ................ 3101
In vitro method(s) for the quality control of vaccines, Insulin zinc injectable suspension (crystalline) .................. 3101
substitution of in vivo method(s) by (5.2.14.)..................... 716 Interferon alfa-2 concentrated solution ............................... 3101
In vivo assay of poliomyelitis vaccine (inactivated) Interferon beta-1a concentrated solution ............................ 3104
(2.7.20.) .................................................................................... 304 Interferon gamma-1b concentrated solution ...................... 3107
Inactivated vaccines for veterinary use, healthy chicken flocks Interferons, assay of (5.6.)........................................................ 777
for the production of (5.2.13.) .............................................. 715 International System (SI) units (1.) ............................................ 3
Indapamide.............................................................................. 3073 Intramammary preparations for veterinary use ................... 974
Index, foam (2.8.24.) ................................................................ 333 Intraruminal delivery systems ................................................ 975
Indian frankincense................................................................ 1562 Intrauterine capsules ................................................................ 975
Indicators, approximate pH of solutions (2.2.4.) .................... 30 Intrauterine foams .................................................................... 975
Indigo plant leaf ...................................................................... 1563 Intrauterine preparations for veterinary use ......................... 975
Indinavir sulfate ...................................................................... 3075 Intrauterine solutions, suspensions ........................................ 975
Indium (111In) chloride solution ........................................... 1278 Intrauterine sticks..................................................................... 975
Indium (111In) oxine solution ................................................ 1279 Intrauterine tablets ................................................................... 975
Indium (111In) pentetate injection ........................................ 1280 Intravesical preparations.......................................................... 977
Indometacin ............................................................................ 3077 Intravesical solutions or suspensions, powders for .............. 978
Inductively coupled plasma-atomic emission spectrometry Intravesical solutions, suspensions and emulsions............... 977
(2.2.57.) .................................................................................... 116 Intravesical solutions, suspensions or emulsions, concentrates
Inductively coupled plasma-mass spectrometry (2.2.58.) ... 117 for ............................................................................................. 978
Infectious bovine rhinotracheitis vaccine (inactivated)..... 1183 Intravitreal preparations .......................................................... 990
Infectious bovine rhinotracheitis vaccine (live).................. 1184 Intrinsic dissolution (2.9.29.) .................................................. 395
Infectious bronchitis vaccine (inactivated), avian .............. 1123 Iobenguane (123I) injection .................................................... 1281
Infectious bronchitis vaccine (live), avian .................. 11.1-4597 Iobenguane (131I) injection for diagnostic use..................... 1282
Infectious bursal disease vaccine (inactivated), avian........ 1126 Iobenguane (131I) injection for therapeutic use................... 1283
Infectious bursal disease vaccine (live), avian............ 11.1-4598 Iobenguane sulfate for radiopharmaceutical prepara-
Infectious chicken anaemia vaccine (live) .................. 11.1-4606 tions........................................................................................ 1283
Infectious encephalomyelitis vaccine (live), avian..... 11.1-4600 Iodinated (125I) human albumin injection ........................... 1277
Infectious enteritis vaccine (inactivated), feline ................. 1172 Iodinated povidone ................................................................ 3775
Infectious enteritis vaccine (live), feline .............................. 1173 Iodine ....................................................................................... 3110
Infectious laryngotracheitis vaccine (live), avian ...... 11.1-4601 Iodine value (2.5.4.).................................................................. 179
Infectious pancreatic necrosis vaccine (inactivated, Iodixanol.................................................................................. 3110
oil-adjuvanted, injectable) for salmonids .......................... 1187 Iodohippurate (sodium) dihydrate for radiopharmaceutical
Infectious rhinotracheitis vaccine (live), turkey ................. 1224 preparations .......................................................................... 1305
Infliximab concentrated solution................................. 11.1-4699 Iodomethylnorcholesterol (131I) injection............................ 1284
Influenza vaccine (inactivated), equine ............................... 1167 Iohexol...................................................................................... 3113
Influenza vaccine (inactivated), porcine.............................. 1204 Ionic concentration, potentiometric determination of using
Influenza vaccine (live, nasal) ............................................... 1057 ion-selective electrodes (2.2.36.)............................................. 69
Influenza vaccine (split virion, inactivated) ........................ 1059 Ions and functional groups, identification reactions of
Influenza vaccine (surface antigen, inactivated)................. 1061 (2.3.1.) ...................................................................................... 139
Ion-selective electrodes, potentiometric determination of Lacosamide.............................................................................. 3185

ionic concentration (2.2.36.) ................................................... 69 Lacosamide infusion .............................................................. 3186
Iopamidol................................................................................. 3117 Lacosamide oral solution....................................................... 3187
Iopanoic acid ........................................................................... 3119 Lacosamide tablets.................................................................. 3189
Iopromide ................................................................................ 3120 Lactic acid................................................................................ 3190
Iotrolan .................................................................................... 3123 Lactic acid, (S)- ....................................................................... 3191
Ioxaglic acid............................................................................. 3125 Lactitol monohydrate ............................................................. 3191
Ipecacuanha liquid extract, standardised ............................ 1564 Lactobionic acid...................................................................... 3193
Ipecacuanha, prepared ........................................................... 1565 Lactose ............................................................................ 11.1-4713
Ipecacuanha root .................................................................... 1566 Lactose monohydrate .................................................... 11.1-4714
Ipecacuanha tincture, standardised...................................... 1568 Lactulose .................................................................................. 3196
Ipratropium bromide ............................................................. 3127 Lactulose, liquid...................................................................... 3198
Irbesartan................................................................................. 3129 Lamivudine.............................................................................. 3200
Irinotecan hydrochloride trihydrate..................................... 3130 Lamotrigine ............................................................................. 3203
Iron (2.4.9.)................................................................................ 152 Lansoprazole ........................................................................... 3204
Iron for homoeopathic preparations.................................... 1828 Largehead atractylodes rhizome ........................................... 1396
Irrigation, preparations for...................................................... 999 Laryngotracheitis vaccine (live), infectious, avian .... 11.1-4601
Isatis root ................................................................................. 1568 Laser light diffraction, particle size analysis by (2.9.31.) .... 396
Isoconazole .............................................................................. 3132 Latanoprost.............................................................................. 3206
Isoconazole nitrate.................................................................. 3134 Laurilsulfate, sodium.............................................................. 3998
Isoelectric focusing (2.2.54.) ................................................... 104 Lauromacrogol 400................................................................. 3207
Isoflurane ................................................................................. 3135 Lauroyl macrogolglycerides................................................... 3210
Isoleucine................................................................................. 3136 Lavender flower ...................................................................... 1579
Isomalt ..................................................................................... 3137 Lavender oil.................................................................... 11.1-4627
Isoniazid.......................................................................... 11.1-4704 Lavender oil, spike.................................................................. 1735
Isophane insulin injection ..................................................... 3093 Lead in sugars (2.4.10.) ............................................................ 152
Isoprenaline hydrochloride ................................................... 3140 Leflunomide ............................................................................ 3211
Isoprenaline sulfate................................................................. 3141 Lemon oil................................................................................. 1582
Isopropyl alcohol .................................................................... 3142 Lemon verbena leaf ................................................................ 1583
Isopropyl isostearate............................................................... 3143 Leptospirosis vaccine (inactivated), bovine......................... 1135
Isopropyl myristate................................................................. 3144 Leptospirosis vaccine (inactivated), canine ......................... 1146
Isopropyl palmitate................................................................. 3144 Letrozole .................................................................................. 3212
Isosorbide dinitrate, diluted ................................................. 3145 Leucine..................................................................................... 3213
Isosorbide mononitrate, diluted .......................................... 3147 Leukaemia vaccine (inactivated), feline............................... 1175
Isotherms (sorption-desorption) and water activity, Leuprorelin .............................................................................. 3215
determination of (water-solid interactions) (2.9.39.)......... 417 Levamisole for veterinary use ............................................... 3216
Isotretinoin .............................................................................. 3148 Levamisole hydrochloride ..................................................... 3217
Isoxsuprine hydrochloride..................................................... 3150 Levetiracetam .......................................................................... 3219
Ispaghula husk ........................................................................ 1570 Levocabastine hydrochloride ................................................ 3220
Ispaghula seed ......................................................................... 1570 Levocarnitine........................................................................... 3222
Isradipine ................................................................................. 3151 Levodopa ................................................................................. 3224
Itraconazole ............................................................................. 3153 Levodropropizine.................................................................... 3225
Ivermectin................................................................................ 3155 Levofloxacin hemihydrate ..................................................... 3227
Ivy leaf ...................................................................................... 1571 Levofolinate hydrate, calcium ............................................... 2180
Levomenthol............................................................................ 3228
J Levomepromazine hydrochloride................................ 11.1-4715
Java tea ..................................................................................... 1572 Levomepromazine maleate.................................................... 3230
Javanese turmeric.................................................................... 1760 Levomethadone hydrochloride ............................................. 3232
Josamycin................................................................................. 3161 Levonorgestrel......................................................................... 3233
Josamycin propionate............................................................. 3163 Levothyroxine sodium ........................................................... 3236
Juniper...................................................................................... 1574 Levulinate dihydrate, calcium ............................................... 2183
Juniper oil ................................................................................ 1575 Lidocaine ................................................................................. 3238
Lidocaine hydrochloride monohydrate ............................... 3239
Light liquid paraffin ............................................................... 3636
K
Light magnesium carbonate .................................................. 3298
Kalium bichromicum for homoeopathic preparations...... 1835 Light magnesium oxide.......................................................... 3304
Kanamycin acid sulfate .......................................................... 3169 Lightyellow sophora root....................................................... 1585
Kanamycin monosulfate ........................................................ 3170 Ligusticum root and rhizome ............................................... 1586
Kaolin, heavy........................................................................... 3171 Lime flower.............................................................................. 1588
Kelp........................................................................................... 1576 Limit tests (2.4.) ........................................................................ 147
Ketamine hydrochloride ........................................................ 3171 Limit tests, standard solutions for (4.1.2.)............................. 628
Ketobemidone hydrochloride ............................................... 3172 Lincomycin hydrochloride .................................................... 3241
Ketoconazole ........................................................................... 3173 Linen thread, sterile, in distributor for veterinary use ..... 1350
Ketoprofen ...................................................................... 11.1-4709 Linoleoyl macrogolglycerides................................................ 3242
Ketorolac trometamol ............................................................ 3177 Linseed ..................................................................................... 1589
Ketotifen hydrogen fumarate ................................................ 3178 Linseed oil, virgin ................................................................... 3243
Knotgrass ................................................................................. 1576 Liothyronine sodium.............................................................. 3244
Krypton (81mKr) inhalation gas ............................................. 1285 Lipophilic solid dosage forms, dissolution test for
Kudzuvine root ....................................................................... 1578 (2.9.42.) .................................................................................... 424
Kudzuvine root, Thomson..................................................... 1749 Liquid chromatography (2.2.29.) ................................. 11.1-4503
Liquid extraction preparations ............................................... 925
L Liquid (fluid) extracts .............................................................. 925
Labetalol hydrochloride......................................................... 3183 Liquid glucose ......................................................................... 2898

Liquid glucose, spray-dried ................................................... 2898 Macrogolglycerol hydroxystearate........................................ 3288

Liquid lactulose....................................................................... 3198 Macrogolglycerol ricinoleate ................................................. 3289
Liquid maltitol ........................................................................ 3316 Macrogols ................................................................................ 3289
Liquid paraffin ........................................................................ 3637 Macrogols, high-molecular-mass ......................................... 3291
Liquid paraffin, light .............................................................. 3636 Magaldrate............................................................................... 3292
Liquid preparations for cutaneous application ..................... 978 Magnesium (2.4.6.)................................................................... 148
Liquid preparations for cutaneous application, Magnesium acetate tetrahydrate ........................................... 3293
veterinary............................................................................... 1008 Magnesium aluminium silicate............................................. 1921
Liquid preparations for oral use ............................................. 980 Magnesium aluminometasilicate .......................................... 3294
Liquid sorbitol (crystallising)................................................ 4042 Magnesium and alkaline-earth metals (2.4.7.)...................... 149
Liquid sorbitol (non-crystallising) ....................................... 4042 Magnesium aspartate dihydrate............................................ 3295
Liquid sorbitol, partially dehydrated.................................... 4043 Magnesium carbonate, heavy................................................ 3297
Liquid sucrose ......................................................................... 4082 Magnesium carbonate, light .................................................. 3298
Liquids, clarity and degree of opalescence of (2.2.1.) ............ 25 Magnesium chloride 4.5-hydrate.......................................... 3298
Liquorice dry extract for flavouring purposes .................... 1590 Magnesium chloride hexahydrate ........................................ 3299
Liquorice root ......................................................................... 1591 Magnesium citrate .................................................................. 3300
Lisinopril dihydrate ................................................................ 3245 Magnesium citrate dodecahydrate........................................ 3300
Lithium carbonate .................................................................. 3247 Magnesium citrate nonahydrate ........................................... 3301
Lithium citrate ........................................................................ 3248 Magnesium fluoratum for homoeopathic preparations..... 1836
Live biotherapeutic products for human use ........................ 935 Magnesium gluconate ............................................................ 3301
Live biotherapeutic products, microbiological examination Magnesium glycerophosphate............................................... 3302
of (tests for enumeration of microbial contaminants) Magnesium hydroxide............................................................ 3303
(2.6.36.) .................................................................................... 262 Magnesium lactate dihydrate ................................................ 3303
Live biotherapeutic products, microbiological examination of Magnesium oxide, heavy ....................................................... 3304
(tests for specified micro-organisms) (2.6.38.) ................... 267 Magnesium oxide, light.......................................................... 3304
L-Methionine ([11C]methyl) injection ......................... 11.1-4617 Magnesium peroxide.............................................................. 3305
Lobeline hydrochloride.......................................................... 3248 Magnesium phosphoricum for homoeopathic
Lomustine ................................................................................ 3249 preparations .......................................................................... 1836
Long pepper ............................................................................ 1592 Magnesium pidolate ............................................................... 3306
Loosestrife ............................................................................... 1593 Magnesium stearate................................................................ 3307
Loperamide hydrochloride.................................................... 3250 Magnesium sulfate heptahydrate .......................................... 3309
Loperamide oxide monohydrate........................................... 3252 Magnesium trisilicate ............................................................. 3310
Lopinavir.................................................................................. 3253 Magnolia biondii flower bud................................................. 1597
Loratadine................................................................................ 3257 Magnolia officinalis bark ....................................................... 1599
Lorazepam ............................................................................... 3259 Magnolia officinalis flower .................................................... 1601
Losartan potassium ................................................................ 3260 Maize oil, refined .................................................................... 3310
Loss on drying (2.2.32.) ............................................................. 63 Maize starch ............................................................................ 3311
Loss on drying of extracts (2.8.17.) ........................................ 327 Malathion................................................................................. 3312
Lotions, eye................................................................................ 970 Maleic acid............................................................................... 3313
Lovage root.............................................................................. 1594 Malic acid ................................................................................ 3314
Lovastatin ................................................................................ 3262 Mallow flower.......................................................................... 1602
Low-molecular-mass heparins..................................... 11.2-4899 Mallow leaf .............................................................................. 1603
Low-substituted carmellose sodium..................................... 2214 Maltitol..................................................................................... 3314
Low-substituted hydroxypropylcellulose ............................. 3045 Maltitol, liquid ........................................................................ 3316
Lozenges and pastilles .............................................................. 987 Maltodextrin............................................................................ 3317
Lozenges, compressed .............................................................. 987 Management of extraneous agents in immunological
Lubricant, silicone oil (3.1.8.).................................................. 462 veterinary medicinal products (5.2.5.)................................. 688
Lufenuron for veterinary use ................................................ 3264 Mandarin epicarp and mesocarp.......................................... 1604
Lutetium (177Lu) solution for radiolabelling........................ 1286 Mandarin oil............................................................................ 1606
Lycopus lucidus herb.............................................................. 1596 Mandragora for homoeopathic preparations...................... 1837
Lymecycline............................................................................. 3266 Manganese gluconate ............................................................. 3318
Lynestrenol .............................................................................. 3268 Manganese glycerophosphate, hydrated .............................. 3318
Lyophilisates, oral ................................................................... 1006 Manganese sulfate monohydrate .......................................... 3319
Lysine acetate ................................................................. 11.2-4905 Mannheimia vaccine (inactivated) for cattle....................... 1188
Lysine acetylsalicylate, DL-..................................................... 3270 Mannheimia vaccine (inactivated) for sheep ...................... 1189
Lysine hydrochloride.............................................................. 3272 Mannitol .................................................................................. 3319
Maprotiline hydrochloride .................................................... 3321
M Marbofloxacin for veterinary use ......................................... 3323
Macrogol 15 hydroxystearate ................................................ 3277 Marek’s disease vaccine (live)................................................ 1190
Macrogol 20 glycerol monostearate...................................... 3278 Marshmallow leaf ................................................................... 1607
Macrogol 30 dipolyhydroxystearate ..................................... 3279 Marshmallow root .................................................................. 1608
Macrogol 40 sorbitol heptaoleate.......................................... 3279 Mass spectrometry (2.2.43.) ...................................................... 83
Macrogol 6 glycerol caprylocaprate...................................... 3277 Mass spectrometry, inductively coupled plasma- (2.2.58.).. 117
Macrogol cetostearyl ether .................................................... 3280 Mass uniformity of single-dose preparations
Macrogol isotridecyl ether..................................................... 3281 (2.9.5.) ........................................................................... 11.1-4523
Macrogol lauryl ether............................................................. 3281 Mastic ....................................................................................... 1609
Macrogol oleate....................................................................... 3283 Mate leaf................................................................................... 1609
Macrogol oleyl ether............................................................... 3284 Materials based on non-plasticised poly(vinyl chloride)
Macrogol poly(vinyl alcohol) grafted copolymer ............... 3284 for containers for non-injectable, aqueous solutions
Macrogol stearate.................................................................... 3286 (3.1.10.) .................................................................................... 463
Macrogol stearyl ether ........................................................... 3286 Materials based on non-plasticised poly(vinyl chloride) for
Macrogolglycerol cocoates..................................................... 3287 containers for solid dosage forms for oral administration
(3.1.11.) .................................................................................... 465
Materials based on plasticised poly(vinyl chloride) for Metal catalyst or metal reagent residues (5.20.).................... 857
containers for aqueous solutions for intravenous infusion Metal catalyst or metal reagent residues, determination of
(3.1.14.) .................................................................................... 471 (2.4.20.) .................................................................................... 154
Materials based on plasticised poly(vinyl chloride) for Metamizole sodium monohydrate........................................ 3357
containers for human blood and blood components Metered-dose preparations for inhalation, non-
(3.3.2.) ...................................................................................... 491 pressurised............................................................................... 995
Materials based on plasticised poly(vinyl chloride) for Metered-dose preparations for inhalation, pressurised ....... 995
tubing used in sets for the transfusion of blood and blood Metformin hydrochloride...................................................... 3359
components (3.3.3.)................................................................ 494 Methacrylate copolymer, basic butylated ............................ 2044
Materials for containers for human blood and blood Methacrylic acid - ethyl acrylate copolymer (1:1).............. 3360
components (3.3.1.)................................................................ 491 Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion
Materials used for the manufacture of containers (3.1.)...... 449 30 per cent ............................................................................. 3361
Matricaria flower .................................................................... 1611 Methacrylic acid - methyl methacrylate copolymer (1:1).. 3362
Matricaria liquid extract ........................................................ 1612 Methacrylic acid - methyl methacrylate copolymer (1:2).. 3363
Matricaria oil........................................................................... 1613 Methadone hydrochloride ..................................................... 3364
Meadowsweet .......................................................................... 1615 Methane ................................................................................... 3366
Measles immunoglobulin, human ........................................ 2998 Methane intermix (2 per cent) in nitrogen ......................... 3367
Measles, mumps and rubella vaccine (live)......................... 1070 Methanesulfonate (methyl, ethyl and isopropyl) in active
Measles, mumps, rubella and varicella vaccine (live) ........ 1071 substances (2.5.38.)................................................................. 195
Measles vaccine (live)............................................................. 1072 Methanesulfonic acid, methanesulfonyl chloride in
Measurement and detection of radioactivity (2.2.66.) ......... 129 (2.5.39.) .................................................................................... 196
Measurement of consistency by penetrometry (2.9.9.)........ 360 Methanesulfonic acid, methyl, ethyl and isopropyl
Mebendazole ........................................................................... 3324 methanesulfonate in (2.5.37.)................................................ 194
Mebeverine hydrochloride .................................................... 3325 Methanesulfonyl chloride in methanesulfonic acid
Meclozine dihydrochloride.................................................... 3327 (2.5.39.) .................................................................................... 196
Medicated chewing gums ........................................................ 967 Methanol.................................................................................. 3367
Medicated chewing gums, dissolution test for (2.9.25.)....... 387 Methanol and 2-propanol, test for (2.9.11.) .......................... 364
Medicated feeding stuffs for veterinary use, premixes for .. 993 Methenamine .......................................................................... 3368
Medicated foams....................................................................... 972 Methionine .............................................................................. 3369
Medicated plasters .................................................................... 991 Methionine ([11C]methyl) injection, L- ....................... 11.1-4617
Medicated tampons ................................................................ 1006 Methionine, DL- ...................................................................... 3370
Medicated vaginal tampons.......................................... 11.1-4594 Methods in pharmacognosy (2.8.).......................................... 321
Medicinal air ........................................................................... 1889 Methods of preparation of homoeopathic stocks and
Medicinal air, synthetic.......................................................... 1891 potentisation ......................................................................... 1790
Medium-chain triglycerides .................................................. 4280 Methods of preparation of sterile products (5.1.1.) ............. 649
Medronic acid for radiopharmaceutical preparations ....... 1287 Methods of pretreatment for preparing traditional Chinese
Medroxyprogesterone acetate................................................ 3329 drugs : general information (5.18.) ....................................... 843
Mefenamic acid....................................................................... 3331 Methotrexate ........................................................................... 3371
Mefloquine hydrochloride............................................ 11.1-4719 Methyl, ethyl and isopropyl benzenesulfonate in active
Megestrol acetate .................................................................... 3333 substances (2.5.41.)................................................................. 198
Meglumine............................................................................... 3335 Methyl, ethyl and isopropyl methanesulfonate in active
Melatonin................................................................................. 3336 substances (2.5.38.)................................................................. 195
Meldonium dihydrate............................................................. 3337 Methyl, ethyl and isopropyl methanesulfonate in
Melilot ...................................................................................... 1616 methanesulfonic acid (2.5.37.) .............................................. 194
Melissa leaf .............................................................................. 1618 Methyl, ethyl and isopropyl toluenesulfonate in active
Melissa leaf dry extract .......................................................... 1619 substances (2.5.40.)................................................................. 197
Meloxicam ............................................................................... 3339 Methyl methacrylate – methacrylic acid copolymer (1:1).. 3362
Melphalan ................................................................................ 3340 Methyl methacrylate - methacrylic acid copolymer (1:2).. 3363
Melting point - capillary method (2.2.14.) .............................. 38 Methyl nicotinate.................................................................... 3373
Melting point - instantaneous method (2.2.16.) ..................... 38 Methyl parahydroxybenzoate................................................ 3374
Melting point - open capillary method (2.2.15.) .................... 38 Methyl parahydroxybenzoate, sodium................................. 4001
Menadione............................................................................... 3342 Methyl salicylate ..................................................................... 3376
Meningococcal group A, C, W135 and Y conjugate Methylaminolevulinate hydrochloride................................. 3377
vaccine ................................................................................... 1073 Methylcellulose ....................................................................... 3379
Meningococcal group C and haemophilus type b conjugate Methyldopa.............................................................................. 3381
vaccine ................................................................................... 1043 Methylene blue........................................................................ 3397
Meningococcal group C conjugate vaccine ......................... 1075 Methylene chloride................................................................. 3382
Meningococcal polysaccharide vaccine ............................... 1076 Methylergometrine maleate .................................................. 3383
Menthol, racemic .................................................................... 3343 Methylhydroxyethylcellulose................................................. 3385
Mepivacaine hydrochloride ................................................... 3344 Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 185
Mepyramine maleate.............................................................. 3345 Methylphenidate hydrochloride ........................................... 3385
Mercaptopurine monohydrate .............................................. 3347 Methylphenobarbital .............................................................. 3387
Mercuric chloride ................................................................... 3348 Methylprednisolone................................................................ 3388
Mercury porosimetry, porosity and pore-size distribution of Methylprednisolone acetate................................................... 3390
solids by (2.9.32.).................................................................... 400 Methylprednisolone hydrogen succinate ............................. 3392
Meropenem trihydrate ........................................................... 3348 Methylpyrrolidone, N- ........................................................... 3394
Mesalazine ............................................................................... 3350 Methylrosanilinium chloride ................................................ 3395
Mesna ....................................................................................... 3353 Methyltestosterone ................................................................. 3396
Mesterolone ............................................................................. 3354 Methylthioninium chloride hydrate ..................................... 3397
Mestranol ................................................................................. 3355 Metixene hydrochloride......................................................... 3398
Metabisulfite, potassium ........................................................ 3767 Metoclopramide...................................................................... 3399
Metabisulfite, sodium............................................................. 4001 Metoclopramide hydrochloride monohydrate.................... 3401
Metacresol................................................................................ 3356 Metolazone .............................................................................. 3402

Metoprolol succinate .............................................................. 3403 Monographs on herbal drug extracts (information chapter)
Metoprolol tartrate ................................................................. 3405 (5.23.) ....................................................................................... 885
Metronidazole ......................................................................... 3407 Monophosphoryl lipid A, 3-O-desacyl-4′- .......................... 2481
Metronidazole benzoate......................................................... 3408 Montelukast sodium............................................................... 3441
Mexiletine hydrochloride ...................................................... 3409 Morantel hydrogen tartrate for veterinary use ................... 3444
Mianserin hydrochloride ....................................................... 3410 Morinda root........................................................................... 1624
Miconazole .............................................................................. 3412 Morphine hydrochloride ....................................................... 3445
Miconazole nitrate......................................................... 11.2-4909 Morphine sulfate..................................................................... 3446
Micro determination of water (2.5.32.).................................. 190 Moss, Iceland........................................................................... 1561
Microbial enumeration tests (microbiological examination of Mother tinctures for homoeopathic preparations .............. 1789
non-sterile products) (2.6.12.) .............................................. 217 Motherwort ............................................................................. 1626
Microbiological assay of antibiotics (2.7.2.) .......................... 278 Motherwort, Chinese ............................................................. 1459
Microbiological examination of cell-based preparations Moulds for allergen products ................................................ 3448
(2.6.27.) .................................................................................... 241 Moutan bark............................................................................ 1627
Microbiological examination of herbal medicinal products for Mouthwashes............................................................................. 985
oral use and extracts used in their preparation (2.6.31.)... 249 Moxidectin for veterinary use............................................... 3449
Microbiological examination of human tissues (2.6.39.)..... 271 Moxifloxacin hydrochloride .................................................. 3452
Microbiological examination of live biotherapeutic Moxonidine .................................................................... 11.1-4720
products: tests for enumeration of microbial contaminants Mucoadhesive preparations..................................................... 987
(2.6.36.) .................................................................................... 262 Mullein flower ......................................................................... 1629
Microbiological examination of live biotherapeutic products: Multidose containers, uniformity and accuracy of delivered
tests for specified micro-organisms (2.6.38.) ...................... 267 doses from (2.9.27.)................................................................ 395
Microbiological examination of non-sterile products : Multivariate statistical process control (5.28.) ........... 11.1-4579
microbial enumeration tests (2.6.12.) .................................. 217 Mumps, measles and rubella vaccine (live)......................... 1070
Microbiological examination of non-sterile products : test for Mumps, measles, rubella and varicella vaccine (live) ........ 1071
specified micro-organisms (2.6.13.) ..................................... 221 Mumps vaccine (live) ............................................................. 1078
Microbiological quality, alternative methods for control of Mupirocin ................................................................................ 3455
(5.1.6.) ...................................................................................... 658 Mupirocin calcium ................................................................. 3457
Microbiological quality of herbal medicinal products for oral Mycobacteria (2.6.2.)................................................................ 210
use and extracts used in their preparation (5.1.8.)............. 668 Mycophenolate mofetil .......................................................... 3458
Microbiological quality of non-sterile pharmaceutical Mycophenolate sodium.......................................................... 3460
preparations and substances for pharmaceutical use Mycoplasma gallisepticum vaccine (inactivated) ............... 1192
(5.1.4.) ...................................................................................... 657 Mycoplasmas (2.6.7.)................................................................ 210
Microbiology, general texts on (5.1.) ..................................... 649 myo-Inositol ............................................................................ 3085
Microcalorimetry and solution calorimetry, characterisation Myrrh ....................................................................................... 1630
of crystalline solids by (2.2.61.) ............................................ 124 Myrrh tincture ........................................................................ 1631
Microcrystalline cellulose ...................................................... 2266 Myxomatosis vaccine (live) for rabbits ................................ 1193
Microcrystalline cellulose and carmellose sodium ............ 3415
Microscopic examination of herbal drugs (2.8.23) .............. 333 N
Microscopy, optical (2.9.37.) ................................................... 413 Nabumetone ............................................................................ 3465
Microscopy, scanning electron (2.9.52.) ................................ 437 N-Acetyltryptophan ............................................................... 1875
Midazolam............................................................................... 3416 N-Acetyltyrosine ..................................................................... 1877
Milbemycin oxime for veterinary use .................................. 3418 Nadolol..................................................................................... 3466
Milk thistle dry extract, refined and standardised ............. 1620 Nadroparin calcium ............................................................... 3467
Milk thistle fruit...................................................................... 1621 Naftidrofuryl hydrogen oxalate ............................................ 3470
Minimising the risk of transmitting animal spongiform Naloxone hydrochloride dihydrate....................................... 3471
encephalopathy agents via human and veterinary medicinal Naltrexone hydrochloride...................................................... 3474
products (5.2.8.)...................................................................... 698 Names of herbal drugs used in traditional Chinese medicine
Minocycline hydrochloride dihydrate.................................. 3421 (5.22.) ............................................................................ 11.1-4573
Minoxidil ................................................................................. 3423 Nandrolone decanoate ........................................................... 3475
Mint oil, partly dementholised ............................................. 1623 Naphazoline hydrochloride ................................................... 3477
Mirabegron..................................................................... 11.2-4910 Naphazoline nitrate ................................................................ 3478
Mirtazapine ............................................................................. 3424 Naproxen ................................................................................. 3480
Misoprostol.............................................................................. 3425 Naproxen sodium ................................................................... 3482
Mites for allergen products ................................................... 3427 Narrow-leaved coneflower root ............................................ 1632
Mitomycin ............................................................................... 3428 Nasal drops ................................................................................ 982
Mitoxantrone hydrochloride ................................................. 3429 Nasal powders ........................................................................... 984
Modafinil ................................................................................. 3431 Nasal preparations .................................................................... 982
Modified-release capsules ........................................................ 967 Nasal preparations, semi-solid................................................ 984
Modified-release granules........................................................ 974 Nasal sprays ............................................................................... 983
Modified-release tablets ......................................................... 1005 Nasal sticks ................................................................................ 984
Mofetil mycophenolate .......................................................... 3458 Nasal washes.............................................................................. 984
Molecular mass distribution in dextrans (2.2.39.).................. 74 Nateglinide .............................................................................. 3484
Molgramostim concentrated solution.................................. 3432 Near-infrared spectroscopy (2.2.40.)........................................ 76
Molsidomine ........................................................................... 3434 Nebivolol hydrochloride ........................................................ 3486
Molybdate dihydrate, sodium ............................................... 4003 Nebulisation, characterisation of preparations for
Mometasone furoate............................................................... 3436 (2.9.44.) .................................................................................... 427
Mometasone furoate monohydrate ...................................... 3439 Nebulisation, preparations for ................................................ 994
Monoclonal antibodies for human use ....................... 11.2-4843 Neohesperidin-dihydrochalcone .......................................... 3487
Monocyte-activation test (2.6.30.).......................................... 244 Neomycin sulfate .................................................................... 3489
Monographs on essential oils (information chapter) Neonatal piglet colibacillosis vaccine (inactivated)............ 1194
(5.30.) ....................................................................................... 915 Neonatal ruminant colibacillosis vaccine (inactivated)..... 1196
Neostigmine bromide............................................................. 3491 Normal immunoglobulin for intramuscular administration,

Neostigmine metilsulfate ....................................................... 3492 human .................................................................................... 2998
Neroli oil .................................................................................. 1634 Normal immunoglobulin for intravenous administration,
Netilmicin sulfate.................................................................... 3493 human .................................................................................... 3000
Nettle leaf................................................................................. 1635 Normal immunoglobulin for subcutaneous administration,
Nettle root................................................................................ 1637 human .................................................................................... 3002
Neurovirulence test of live viral vaccines (2.6.18.)............... 234 Nortriptyline hydrochloride.................................................. 3547
Nevirapine ............................................................................... 3495 Noscapine ................................................................................ 3549
Nevirapine hemihydrate ........................................................ 3496 Noscapine hydrochloride hydrate......................................... 3550
Newcastle disease vaccine (inactivated)............................... 1197 Notoginseng root .................................................................... 1639
Newcastle disease vaccine (live)................................... 11.1-4608 Notopterygium rhizome and root ........................................ 1640
Niaouli oil, cineole type ......................................................... 1638 Nuclear magnetic resonance spectrometry (2.2.33.).............. 63
Nicardipine hydrochloride .................................................... 3497 Nuclear magnetic resonance spectrometry, peptide
Nicergoline .............................................................................. 3498 identification by (2.2.64.)....................................................... 128
Nickel in hydrogenated vegetable oils (2.4.31.) .................... 173 Nucleated cell count and viability (2.7.29.) ........................... 312
Nickel in polyols (2.4.15.) ........................................................ 153 Nucleic acid amplification techniques (2.6.21.) .................... 236
Niclosamide............................................................................. 3500 Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 184
Niclosamide monohydrate .................................................... 3501 Numeration of CD34/CD45+ cells in haematopoietic products
Nicorandil................................................................................ 3502 (2.7.23.) .................................................................................... 307
Nicotinamide........................................................................... 3503 Nutmeg oil ............................................................................... 1643
Nicotine.................................................................................... 3504 Nux-vomica for homoeopathic preparations ...................... 1839
Nicotine ditartrate dihydrate................................................. 3505 Nystatin.................................................................................... 3551
Nicotine resinate ..................................................................... 3507
Nicotinic acid .......................................................................... 3508 O
Nifedipine ................................................................................ 3510 O-Acetyl in polysaccharide vaccines (2.5.19.)....................... 185
Niflumic acid........................................................................... 3511 Oak bark .................................................................................. 1644
Nifuroxazide............................................................................ 3512 Octoxinol 10 ............................................................................ 3555
Nikethamide............................................................................ 3514 Octreotide....................................................................... 11.1-4725
Nilotinib hydrochloride monohydrate................................. 3514 Octyl gallate............................................................................. 3557
Nilutamide............................................................................... 3516 Octyldodecanol ....................................................................... 3558
Nimesulide............................................................................... 3518 Odour (2.3.4.)............................................................................ 143
Nimodipine ............................................................................. 3519 Odour and taste of essential oils (2.8.8.)................................ 322
Nitrazepam .............................................................................. 3520 Ofloxacin.................................................................................. 3558
Nitrendipine ............................................................................ 3521 Oils, essential............................................................................. 922
Nitric acid ................................................................................ 3522 Oils, essential, monographs on (information chapter)
Nitric oxide.............................................................................. 3523 (5.30.) ....................................................................................... 915
Nitrofural ................................................................................. 3524 Oils, fatty, identification by thin-layer chromatography
Nitrofurantoin......................................................................... 3525 (2.3.2.) ...................................................................................... 142
Nitrogen ................................................................................... 3526 Oils, fatty, vegetable.................................................................. 960
Nitrogen determination by sulfuric acid digestion (2.5.9.).. 182 Oils rich in omega-3 acids, composition of fatty acids in
Nitrogen determination, primary aromatic amino (2.5.8.).. 181 (2.4.29.) .................................................................................... 171
Nitrogen, low-oxygen............................................................. 3527 Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 174
Nitrogen monoxide and nitrogen dioxide in gases Ointments ................................................................................ 1003
(2.5.26.) .................................................................................... 188 Olanzapine............................................................................... 3560
Nitroprusside, sodium ........................................................... 4004 Olanzapine embonate monohydrate .................................... 3561
Nitrous oxide........................................................................... 3527 Olanzapine pamoate monohydrate ...................................... 3561
Nitrous oxide in gases (2.5.35.)............................................... 194 Oleic acid ................................................................................. 3563
Nizatidine ................................................................................ 3529 Oleoresins .................................................................................. 926
N-Methylpyrrolidone ............................................................. 3394 Oleoyl macrogolglycerides .................................................... 3563
NMR spectrometry (2.2.33.) ..................................................... 63 Oleyl alcohol............................................................................ 3564
NMR spectrometry, peptide identification by (2.2.64.)....... 128 Olive leaf .................................................................................. 1644
N,N-Dimethylaniline (2.4.26.) ................................................ 168 Olive leaf dry extract .............................................................. 1645
N-Nitrosamines in active substances (2.5.42.) ...................... 199 Olive oil, refined ..................................................................... 3565
Nomegestrol acetate ............................................................... 3531 Olive oil, virgin ....................................................................... 3566
Nonoxinol 9............................................................................. 3532 Olmesartan medoxomil ......................................................... 3567
Non-pressurised metered-dose preparations for Olsalazine sodium .................................................................. 3568
inhalation................................................................................. 995 Omega-3 acids, composition of fatty acids in oils rich in
Non-sterile pharmaceutical preparations and substances for (2.4.29.) .................................................................................... 171
pharmaceutical use, microbiological quality of (5.1.4.)..... 657 Omega-3 acids, fish oil rich in .............................................. 2773
Non-sterile products, microbiological examination of Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 174
(microbial enumeration tests) (2.6.12.) ............................... 217 Omega-3-acid ethyl esters 60 ................................................ 3571
Non-sterile products, microbiological examination of (test for Omega-3-acid ethyl esters 90 ................................................ 3573
specified micro-organisms) (2.6.13.).................................... 221 Omega-3-acid triglycerides ................................................... 3575
Noradrenaline hydrochloride................................................ 3532 Omeprazole ............................................................................. 3578
Noradrenaline tartrate ........................................................... 3534 Omeprazole magnesium ........................................................ 3579
Norepinephrine hydrochloride ............................................. 3532 Omeprazole sodium ............................................................... 3581
Norepinephrine tartrate......................................................... 3534 Ondansetron hydrochloride dihydrate ....................... 11.1-4726
Norethisterone ........................................................................ 3535 Opalescence of liquids, clarity and degree of (2.2.1.)............. 25
Norethisterone acetate ........................................................... 3537 Ophthalmic inserts ................................................................... 972
Norfloxacin.............................................................................. 3538 Opium dry extract, standardised.......................................... 1646
Norflurane ............................................................................... 3540 Opium, prepared .................................................................... 1647
Norgestimate ........................................................................... 3546 Opium, raw.............................................................................. 1649
Norgestrel ................................................................................ 3547

Opium tincture, standardised ............................................... 1650 Paraben, propyl ....................................................................... 3821

Optical microscopy (2.9.37.) ................................................... 413 Paraben, sodium ethyl............................................................ 3988
Optical rotation (2.2.7.) ............................................................. 31 Paraben, sodium methyl ........................................................ 4001
Oral drops.................................................................................. 981 Paraben, sodium propyl......................................................... 4009
Oral lyophilisates .................................................................... 1006 Paracetamol ............................................................................. 3634
Oral powders............................................................................. 992 Paraffin, hard........................................................................... 3635
Oral solutions, emulsions and suspensions........................... 981 Paraffin, light liquid ............................................................... 3636
Oral use, liquid preparations for ............................................ 980 Paraffin, liquid ........................................................................ 3637
Oral use, veterinary semi-solid preparations for................ 1009 Paraffin, white soft.................................................................. 3637
Orbifloxacin for veterinary use ............................................. 3584 Paraffin, yellow soft ................................................................ 3638
Orciprenaline sulfate .............................................................. 3585 Parahydroxybenzoate, butyl .................................................. 2144
Oregano ................................................................................... 1652 Parahydroxybenzoate, ethyl .................................................. 2717
Organ preservation, solutions for......................................... 4023 Parahydroxybenzoate, methyl ............................................... 3374
Oriental cashew for homoeopathic preparations ............... 1813 Parahydroxybenzoate, propyl................................................ 3821
Orientvine stem ...................................................................... 1653 Parahydroxybenzoate, sodium ethyl .................................... 3988
Orodispersible films ................................................................. 987 Parahydroxybenzoate, sodium methyl................................. 4001
Orodispersible tablets ............................................................ 1006 Parahydroxybenzoate, sodium propyl.................................. 4009
Oromucosal capsules................................................................ 987 Parainfluenza virus vaccine (live), bovine ........................... 1136
Oromucosal drops .................................................................... 986 Parainfluenza virus vaccine (live), canine ........................... 1147
Oromucosal preparations ........................................................ 985 Paraldehyde ............................................................................. 3639
Oromucosal preparations, semi-solid .................................... 986 Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),
Oromucosal solutions, emulsions and suspensions ............. 986 avian ....................................................................................... 1197
Oromucosal sprays ................................................................... 985 Paramyxovirus 1 (Newcastle disease) vaccine (live),
Oropharyngeal sprays .............................................................. 986 avian .............................................................................. 11.1-4608
Orphenadrine citrate.............................................................. 3587 Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1131
Orphenadrine hydrochloride ................................................ 3588 Parenteral preparations............................................................ 988
Oseltamivir phosphate ........................................................... 3589 Parenteral preparations, depyrogenation of items used in the
Osmolality (2.2.35.) .................................................................... 69 production of (5.1.12.) ........................................................... 674
Ouabain ................................................................................... 3592 Parenteral preparations, test for extractable volume of
Oxacillin sodium monohydrate ............................................ 3593 (2.9.17.) .................................................................................... 369
Oxaliplatin ............................................................................... 3595 Parnaparin sodium ................................................................. 3640
Oxazepam ................................................................................ 3598 Paroxetine hydrochloride ...................................................... 3640
Oxcarbazepine......................................................................... 3599 Paroxetine hydrochloride hemihydrate ............................... 3643
Oxeladin hydrogen citrate ..................................................... 3601 Particle size analysis by laser light diffraction (2.9.31.) ....... 396
Oxfendazole for veterinary use ............................................. 3602 Particles, fine, aerodynamic assessment of in preparations for
Oxidising substances (2.5.30.)................................................. 189 inhalation (2.9.18.) ................................................................. 369
Oxitropium bromide .............................................................. 3603 Particle-size distribution estimation by analytical sieving
Oxolinic acid ........................................................................... 3604 (2.9.38.) ......................................................................... 11.1-4523
Oxybuprocaine hydrochloride .............................................. 3605 Particulate contamination, recommendations on testing of :
Oxybutynin hydrochloride .................................................... 3607 visible particles (5.17.2.) ........................................................ 839
Oxycodone hydrochloride ..................................................... 3608 Particulate contamination : sub-visible particles (2.9.19.) ... 382
Oxygen ..................................................................................... 3610 Particulate contamination : sub-visible particles in
Oxygen (15O) ........................................................................... 1289 non-injectable liquid preparations (2.9.53.)........................ 441
Oxygen (93 per cent).............................................................. 3610 Particulate contamination : visible particles (2.9.20.)........... 385
Oxygen in gases (2.5.27.) ......................................................... 188 Parvovirosis vaccine (inactivated), canine........................... 1148
Oxygen-flask method (2.5.10.)................................................ 182 Parvovirosis vaccine (inactivated), porcine......................... 1206
Oxymetazoline hydrochloride............................................... 3612 Parvovirosis vaccine (live), canine........................................ 1149
Oxytetracycline dihydrate...................................................... 3613 Passionflower herb.................................................................. 1657
Oxytetracycline hydrochloride.............................................. 3615 Passionflower herb dry extract.............................................. 1658
Oxytocin ......................................................................... 11.2-4917 Pastes ........................................................................................ 1003
Oxytocin concentrated solution............................................ 3618 Pasteurella vaccine (inactivated) for sheep.......................... 1201
Pastilles and lozenges ............................................................... 987
P Patches ....................................................................................... 990
Paclitaxel .................................................................................. 3621 Patches, dissolution test for (2.9.4.)........................................ 355
Pale coneflower root............................................................... 1655 Pea starch................................................................................. 3645
Palmitic acid............................................................................ 3625 Peach seed................................................................................ 1660
Pamidronate disodium pentahydrate................................... 3626 Pefloxacin mesilate dihydrate................................................ 3646
Pancreas powder ..................................................................... 3627 Pelargonium root .................................................................... 1661
Pancreatic necrosis vaccine (inactivated, oil-adjuvanted, Pemetrexed disodium 2.5-hydrate............................... 11.2-4921
injectable) for salmonids, infectious .................................. 1187 Pemetrexed disodium heptahydrate............................ 11.2-4923
Pancuronium bromide ........................................................... 3629 Penbutolol sulfate ................................................................... 3652
Panleucopenia vaccine (inactivated), feline ........................ 1172 Penetrometry, measurement of consistency by (2.9.9.) ....... 360
Panleucopenia vaccine (live), feline ..................................... 1173 Penicillamine........................................................................... 3653
Pansy, wild (flowering aerial parts)...................................... 1776 Penicillin G (benzathine) tetrahydrate................................. 2071
Pantoprazole sodium sesquihydrate..................................... 3631 Penicillin G potassium ........................................................... 2073
Pantothenate, calcium ................................................... 11.2-4877 Penicillin G (procaine) monohydrate................................... 2075
Papaverine hydrochloride...................................................... 3632 Penicillin G sodium................................................................ 2077
Paper chromatography (2.2.26.) ............................................... 52 Penicillin V .............................................................................. 3686
Papillomavirus vaccine (rDNA), human ............................ 1054 Penicillin V (benzathine) tetrahydrate................................. 3688
Paraben, butyl ......................................................................... 2144 Penicillin V potassium ........................................................... 3690
Paraben, ethyl.......................................................................... 2717 Pentaerythrityl tetranitrate, diluted...................................... 3655
Paraben, methyl ...................................................................... 3374 Pentamidine diisetionate ....................................................... 3657
Pentazocine.............................................................................. 3658
Pentazocine hydrochloride.................................................... 3658 Phenothiazines, identification by thin-layer chromatography

Pentazocine lactate ................................................................. 3659 (2.3.3.) ...................................................................................... 143
Pentetate sodium calcium hydrate for radiopharmaceutical Phenoxybenzamine hydrochloride....................................... 3684
preparations .......................................................................... 1290 Phenoxyethanol ...................................................................... 3685
Pentobarbital ........................................................................... 3660 Phenoxymethylpenicillin ....................................................... 3686
Pentobarbital sodium ............................................................. 3661 Phenoxymethylpenicillin (benzathine) tetrahydrate.......... 3688
Pentoxifylline .......................................................................... 3662 Phenoxymethylpenicillin potassium .................................... 3690
Pentoxyverine hydrogen citrate ............................................ 3664 Phentolamine mesilate ........................................................... 3691
Peony root, red........................................................................ 1662 Phenylalanine .......................................................................... 3693
Peony root, white .................................................................... 1663 Phenylbutazone....................................................................... 3694
Pepper ...................................................................................... 1665 Phenylbutyrate, sodium ......................................................... 4005
Pepper, long............................................................................. 1592 Phenylephrine ......................................................................... 3696
Peppermint leaf....................................................................... 1667 Phenylephrine hydrochloride................................................ 3697
Peppermint leaf dry extract................................................... 1668 Phenylmercuric acetate.......................................................... 3699
Peppermint oil ........................................................................ 1669 Phenylmercuric borate........................................................... 3699
Pepsin powder......................................................................... 3665 Phenylmercuric nitrate .......................................................... 3700
Peptide identification by nuclear magnetic resonance Phenylpropanolamine hydrochloride .................................. 3700
spectrometry (2.2.64.)............................................................ 128 Phenytoin................................................................................. 3702
Peptide mapping (2.2.55.)........................................................ 106 Phenytoin sodium................................................................... 3703
Peptides, synthetic, acetic acid in (2.5.34.) ............................ 194 Phloroglucinol......................................................................... 3705
Perborate, hydrated sodium .................................................. 4004 Phloroglucinol dihydrate ....................................................... 3706
Pergolide mesilate................................................................... 3667 Pholcodine monohydrate ...................................................... 3708
Perindopril tert-butylamine .................................................. 3668 Phosphates (2.4.11.).................................................................. 152
Peritoneal dialysis, solutions for ........................................... 3671 Phospholipids for injection, egg ........................................... 2626
Permethrin (25:75) ................................................................. 3673 Phospholipids for injection, soya.......................................... 4045
Peroxide value (2.5.5.).............................................................. 180 Phosphoric acid, concentrated.............................................. 3709
Perphenazine........................................................................... 3675 Phosphoric acid, dilute .......................................................... 3710
Pertussis (acellular, component), diphtheria and tetanus Phosphorus in polysaccharide vaccines (2.5.18.) ................. 184
vaccine (adsorbed) ............................................................... 1021 Phthalylsulfathiazole .............................................................. 3710
Pertussis (acellular, component), diphtheria and tetanus Physical and physico-chemical methods (2.2.) ....................... 25
vaccine (adsorbed, reduced antigen(s) content)............... 1022 Physostigmine salicylate ........................................................ 3711
Pertussis (acellular, component), diphtheria, tetanus and Phytomenadione, all-rac- ...................................................... 3712
haemophilus type b conjugate vaccine (adsorbed)........... 1026 Phytonadione, all-rac-............................................................ 3712
Pertussis (acellular, component), diphtheria, tetanus and Phytosterol............................................................................... 3713
poliomyelitis (inactivated) vaccine (adsorbed)................. 1029 Picosulfate, sodium ................................................................ 4006
Pertussis (acellular, component), diphtheria, tetanus and Picotamide monohydrate....................................................... 3714
poliomyelitis (inactivated) vaccine (adsorbed, reduced Piglet colibacillosis vaccine (inactivated), neonatal ........... 1194
antigen(s) content) ............................................................... 1031 Pillules for homoeopathic preparations............................... 1805
Pertussis (acellular, component), diphtheria, tetanus, Pillules, homoeopathic, coated ............................................. 1806
hepatitis B (rDNA), poliomyelitis (inactivated) and Pillules, homoeopathic, impregnated................................... 1806
haemophilus type b conjugate vaccine (adsorbed)........... 1033 Pilocarpine hydrochloride ..................................................... 3715
Pertussis (acellular, component), diphtheria, tetanus, Pilocarpine nitrate .................................................................. 3716
poliomyelitis (inactivated) and haemophilus type b conjugate Pimobendan for veterinary use............................................. 3718
vaccine (adsorbed) ............................................................... 1035 Pimozide .................................................................................. 3719
Pertussis toxin (residual) (2.6.33.) .......................................... 254 Pindolol.................................................................................... 3720
Pertussis vaccine (acellular), assay of (2.7.16.)...................... 301 Pine (dwarf) oil....................................................................... 1494
Pertussis vaccine (acellular, component, adsorbed)........... 1079 Pine sylvestris oil .................................................................... 1671
Pertussis vaccine (acellular, co-purified, adsorbed) ........... 1081 Pioglitazone hydrochloride ................................................... 3721
Pertussis vaccine (whole cell, adsorbed).............................. 1082 Pipemidic acid trihydrate ...................................................... 3722
Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 290 Piperacillin monohydrate ...................................................... 3723
Pertussis (whole cell), diphtheria and tetanus vaccine Piperacillin sodium ................................................................ 3727
(adsorbed) ............................................................................. 1023 Piperazine adipate .................................................................. 3730
Pertussis (whole cell), diphtheria, tetanus and poliomyelitis Piperazine citrate .................................................................... 3731
(inactivated) vaccine (adsorbed) ........................................ 1037 Piperazine hydrate .................................................................. 3732
Peru balsam ............................................................................. 1670 Piracetam ................................................................................. 3733
Pessaries .......................................................................... 11.1-4593 Pirenzepine dihydrochloride monohydrate ........................ 3734
Pesticide residues (2.8.13.)....................................................... 324 Piretanide................................................................................. 3735
Pethidine hydrochloride ........................................................ 3676 Pirfenidone .............................................................................. 3736
Petroleum rectificatum for homoeopathic preparations ... 1841 Piroxicam................................................................................. 3737
pH of solutions, approximate (2.2.4.)....................................... 30 Pivampicillin ........................................................................... 3739
pH, potentiometric determination of (2.2.3.) ......................... 29 Pivmecillinam hydrochloride....................................... 11.1-4731
Pharmaceutical preparations................................................... 939 Plasma for fractionation, human.......................................... 3004
Pharmaceutical technical procedures (2.9.) .......................... 345 Plasma (pooled and treated for virus inactivation),
Pharmacognosy, methods in (2.8.)......................................... 321 human .................................................................................... 3005
Pharmacopoeial harmonisation (5.8.) ................................... 791 Plasmid vectors for human use, bacterial cells used for the
Phenazone................................................................................ 3677 manufacture of........................................................................ 817
Pheniramine maleate.............................................................. 3678 Plasmin inhibitor, assay of human (2.7.25.).......................... 310
Phenobarbital .......................................................................... 3680 Plasters, medicated ................................................................... 991
Phenobarbital sodium............................................................ 3681 Plastic additives (3.1.13.) ......................................................... 467
Phenol ...................................................................................... 3682 Plastic containers and closures for pharmaceutical use
Phenol in immunosera and vaccines (2.5.15.) ...................... 184 (3.2.2.) ...................................................................................... 485
Phenolphthalein...................................................................... 3683 Plastic containers for aqueous solutions for infusion
Phenolsulfonphthalein ........................................................... 3684 (3.2.2.1.) ................................................................................... 486

Plastic containers for human blood and blood components, Poly(vinyl acetate) dispersion 30 per cent ........................... 3754
sterile (3.3.4.)........................................................................... 497 Poly(vinyl alcohol).................................................................. 3756
Plastic syringes, single-use, sterile (3.3.8.)............................. 503 Poly(vinyl alcohol) macrogol grafted copolymer ............... 3284
Platycodon root....................................................................... 1672 Poly(vinyl chloride) (non-plasticised) for containers for solid
Pneumococcal polysaccharide conjugate vaccine dosage forms for oral administration, materials based on
(adsorbed) ............................................................................. 1084 (3.1.11.) .................................................................................... 465
Pneumococcal polysaccharide vaccine ................................ 1086 Poly(vinyl chloride), non-plasticised, materials based on for
Pneumonia vaccine (inactivated), porcine enzootic .......... 1203 containers for non-injectable aqueous solutions (3.1.10.).. 463
Podophyllotoxin...................................................................... 3742 Poly(vinyl chloride), plasticised, empty sterile containers of,
Poliomyelitis (inactivated), diphtheria and tetanus vaccine for human blood and blood components (3.3.5.) .............. 499
(adsorbed, reduced antigen(s) content)............................. 1025 Poly(vinyl chloride), plasticised, materials based on, for
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis containers for aqueous solutions for intravenous infusion
(acellular, component) vaccine (adsorbed)....................... 1029 (3.1.14.) .................................................................................... 471
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis Poly(vinyl chloride), plasticised, materials based on, for
(acellular, component) vaccine (adsorbed, reduced antigen(s) containers for human blood and blood components
content).................................................................................. 1031 (3.3.2.) ...................................................................................... 491
Poliomyelitis (inactivated), diphtheria, tetanus and pertussis Poly(vinyl chloride), plasticised, materials based on, for
(whole cell) vaccine (adsorbed) .......................................... 1037 tubing used in sets for the transfusion of blood and blood
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis components (3.3.3.)................................................................ 494
(acellular, component) and haemophilus type b conjugate Poly(vinyl chloride), plasticised, sterile containers of, for
vaccine (adsorbed) ............................................................... 1035 human blood containing anticoagulant solution (3.3.6.) .. 500
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis Poppy petals, red..................................................................... 1691
(acellular, component), hepatitis B (rDNA) and haemophilus Porcine actinobacillosis vaccine (inactivated) .................... 1202
type b conjugate vaccine (adsorbed) .................................. 1033 Porcine enzootic pneumonia vaccine (inactivated) ........... 1203
Poliomyelitis vaccine (inactivated) ....................................... 1087 Porcine influenza vaccine (inactivated) ............................... 1204
Poliomyelitis vaccine (inactivated), in vivo assay of Porcine insulin ........................................................................ 3096
(2.7.20.) .................................................................................... 304 Porcine parvovirosis vaccine (inactivated).......................... 1206
Poliomyelitis vaccine (oral) ................................................... 1090 Porcine progressive atrophic rhinitis vaccine
Pollens for allergen products................................................. 3743 (inactivated) .......................................................................... 1207
Poloxamers .............................................................................. 3744 Pore-size distribution of solids by mercury porosimetry,
Polyacrylate dispersion 30 per cent ...................................... 3746 porosity and (2.9.32.) ............................................................. 400
Polyamide suture, sterile, in distributor for veterinary Poria ......................................................................................... 1677
use........................................................................................... 1350 Porosimetry, mercury, porosity and pore-size distribution of
Poly(ethylene - vinyl acetate) for containers and tubing for solids by (2.9.32.).................................................................... 400
total parenteral nutrition preparations (3.1.7.)................... 460 Porosity and pore-size distribution of solids by mercury
Polyethylene oxides, high-molecular-mass ......................... 3291 porosimetry (2.9.32.).............................................................. 400
Polyethylene terephthalate for containers for preparations not Porosity of sintered-glass filters (2.1.2.)................................... 17
for parenteral use (3.1.15.) .................................................... 474 Porous solids including powders, wettability of (2.9.45.) .... 429
Poly(ethylene terephthalate) suture, sterile, in distributor for Potassium (2.4.12.) ................................................................... 152
veterinary use........................................................................ 1351 Potassium acetate.................................................................... 3757
Polyethylene with additives for containers for parenteral Potassium bromide................................................................. 3757
preparations and for ophthalmic preparations (3.1.5.)...... 453 Potassium carbonate............................................................... 3758
Polyethylene without additives for containers for parenteral Potassium chloride ................................................................. 3759
preparations and for ophthalmic preparations (3.1.4.)...... 452 Potassium citrate..................................................................... 3759
Polyethyleneglycols................................................................. 3289 Potassium clavulanate ............................................................ 3760
Polyethyleneglycols, high-molecular-mass.......................... 3291 Potassium clavulanate, diluted.............................................. 3762
Polygonum cuspidatum rhizome and root.......................... 1673 Potassium dichromate for homoeopathic preparations..... 1835
Polygonum orientale fruit ..................................................... 1675 Potassium dihydrogen phosphate......................................... 3764
Polymorphism (5.9.)................................................................. 795 Potassium hydrogen aspartate hemihydrate ....................... 3764
Polymyxin B sulfate ................................................................ 3747 Potassium hydrogen carbonate ............................................. 3765
Polyolefins (3.1.3.) .................................................................... 449 Potassium hydrogen tartrate ................................................. 3766
Polyoxyl castor oil................................................................... 3289 Potassium hydroxide .............................................................. 3766
Polyoxyl hydrogenated castor oil .......................................... 3288 Potassium iodide..................................................................... 3767
Polyoxypropylene stearyl ether ............................................. 3748 Potassium metabisulfite ......................................................... 3767
Polypropylene for containers and closures for parenteral Potassium nitrate .................................................................... 3768
preparations and ophthalmic preparations (3.1.6.)............ 457 Potassium perchlorate............................................................ 3769
Polysaccharide vaccines for human use, conjugated, carrier Potassium permanganate....................................................... 3769
proteins for the production of (5.2.11.) ............................... 711 Potassium sodium tartrate tetrahydrate .............................. 3770
Polysaccharide vaccines, hexosamines in (2.5.20.)............... 185 Potassium sorbate ................................................................... 3770
Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 185 Potassium sulfate .................................................................... 3771
Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 184 Potato starch............................................................................ 3771
Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 185 Potentiometric determination of ionic concentration using
Polysaccharide vaccines, phosphorus in (2.5.18.)................. 184 ion-selective electrodes (2.2.36.)............................................. 69
Polysaccharide vaccines, protein in (2.5.16.)......................... 184 Potentiometric determination of pH (2.2.3.) .......................... 29
Polysaccharide vaccines, ribose in (2.5.31.) .......................... 190 Potentiometric titration (2.2.20.).............................................. 41
Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 186 Potentisation, methods of preparation of homoeopathic stocks
Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 186 and.......................................................................................... 1790
Polysorbate 20 ................................................................ 11.2-4925 Poultices................................................................................... 1003
Polysorbate 40 ................................................................ 11.2-4926 Pour-on preparations ............................................................. 1008
Polysorbate 60 ................................................................ 11.2-4927 Povidone .................................................................................. 3772
Polysorbate 80 ................................................................ 11.2-4928 Povidone, iodinated................................................................ 3775
Polystyrene sulfonate, sodium .............................................. 4007 Powder fineness (2.9.35.) ......................................................... 410
Poly(vinyl acetate) .................................................................. 3753 Powder flow (2.9.36.)................................................................ 410
Powder flow properties by shear cell methods (2.9.49.) ...... 434 Products with risk of transmitting agents of animal spongiform
Powdered cellulose ................................................................. 2270 encephalopathies .................................................................... 942
Powders and granules for oral solutions and suspensions .. 981 Progenitor cells, human haematopoietic, colony-forming cell
Powders and granules for syrups ............................................ 981 assay for (2.7.28.) .................................................................... 311
Powders and tablets for rectal solutions or suspensions.... 1001 Progesterone............................................................................ 3804
Powders and tablets for vaginal solutions or suspensions.. 11.1- Progressive atrophic rhinitis vaccine (inactivated),
4594 porcine ................................................................................... 1207
Powders, bulk density and tapped density of (2.9.34.)......... 407 Proguanil hydrochloride........................................................ 3806
Powders, ear .............................................................................. 970 Proline...................................................................................... 3808
Powders, effervescent ............................................................... 992 Promazine hydrochloride ............................................. 11.2-4931
Powders for cutaneous application......................................... 991 Promethazine hydrochloride................................................. 3810
Powders for eye drops and powders for eye lotions ............. 971 Propacetamol hydrochloride................................................. 3811
Powders for injections or infusions........................................ 989 Propafenone hydrochloride................................................... 3812
Powders for intravesical solutions or suspensions ............... 978 Propanol................................................................................... 3814
Powders for oral drops............................................................. 981 Propanol and methanol, 2-, test for (2.9.11.) ........................ 364
Powders, inhalation .................................................................. 997 Propantheline bromide .......................................................... 3815
Powders, nasal........................................................................... 984 Propofol ................................................................................... 3816
Powders, oral ............................................................................. 992 Propranolol hydrochloride .................................................... 3818
Powders, wettability of porous solids including (2.9.45.) .... 429 Propyl gallate........................................................................... 3819
Pramipexole dihydrochloride monohydrate ....................... 3776 Propyl parahydroxybenzoate................................................. 3821
Prasugrel hydrochloride......................................................... 3777 Propyl parahydroxybenzoate, sodium ................................. 4009
Pravastatin sodium ................................................................. 3779 Propylene glycol...................................................................... 3822
Prazepam ................................................................................. 3780 Propylene glycol dicaprylocaprate........................................ 3822
Praziquantel............................................................................. 3782 Propylene glycol dilaurate ..................................................... 3823
Prazosin hydrochloride.......................................................... 3783 Propylene glycol monocaprylate.................................. 11.2-4932
Precursors for radiopharmaceutical preparations, Propylene glycol monolaurate............................................... 3824
chemical................................................................................... 920 Propylene glycol monopalmitostearate................................ 3825
Prednicarbate .......................................................................... 3784 Propylene glycol monostearate ............................................. 3825
Prednisolone............................................................................ 3786 Propylthiouracil ............................................................. 11.2-4933
Prednisolone acetate............................................................... 3788 Propyphenazone ..................................................................... 3827
Prednisolone pivalate ............................................................. 3789 Protamine sulfate.................................................................... 3828
Prednisolone sodium phosphate........................................... 3790 Protein assays, host-cell (2.6.34.)............................................ 256
Prednisone...................................................................... 11.2-4929 Protein C, human, assay of (2.7.30.)....................................... 314
Pregabalin ................................................................................ 3794 Protein in polysaccharide vaccines (2.5.16.) ......................... 184
Pregelatinised hydroxypropyl starch ........................... 11.2-4959 Protein S, human, assay of (2.7.31.) ....................................... 315
Pregelatinised starch............................................................... 4065 Protein, total (2.5.33.) .............................................................. 191
Prekallikrein activator (2.6.15.)............................................... 230 Prothrombin complex, human.............................................. 3008
Premixes for medicated feeding stuffs for veterinary use ... 993 Protirelin.................................................................................. 3829
Preparations for inhalation ..................................................... 993 Proxyphylline .......................................................................... 3831
Preparations for inhalation : aerodynamic assessment of fine Pseudoephedrine hydrochloride........................................... 3831
particles (2.9.18.) .................................................................... 369 PSMA-1007 (18F) injection .................................................... 1292
Preparations for irrigation....................................................... 999 PSMA-11 (gallium (68Ga)) injection .................................... 1276
Preparations for nebulisation.................................................. 994 Psyllium seed........................................................................... 1678
Preparations for nebulisation : characterisation (2.9.44.) .... 427 Pullulan.................................................................................... 3832
Preparations to be converted into vapour ............................. 994 Pulsatilla chinensis rhizome and root......................... 11.1-4628
Preservative and anticoagulant solutions for human Pulsed electrochemical detection and direct amperometric
blood ...................................................................................... 1975 detection (2.2.63.)................................................................... 126
Pressurised metered-dose preparations for inhalation ........ 995 Pumpkin seed................................................................. 11.2-4858
Pressurised pharmaceutical preparations.............................. 999 Purified water .......................................................................... 4391
Pretreatment for preparing traditional Chinese drugs, Purple coneflower herb.......................................................... 1679
methods of (general information) (5.18.)............................ 843 Purple coneflower herb expressed juice, stabilised with
Prilocaine................................................................................. 3795 ethanol ................................................................................... 1681
Prilocaine hydrochloride ....................................................... 3796 Purple coneflower herb expressed juice, stabilised without
Primaquine diphosphate........................................................ 3798 ethanol .......................................................................... 11.1-4630
Primary aromatic amino-nitrogen, determination of Purple coneflower root .......................................................... 1684
(2.5.8.) ...................................................................................... 181 Pycnometric density of solids, gas (2.9.23.) .......................... 386
Primary standards for volumetric solutions (4.2.1.) ............ 638 Pygeum africanum bark ........................................................ 1687
Primidone ................................................................................ 3799 Pyrantel embonate.................................................................. 3833
Primula root ............................................................................ 1677 Pyrazinamide .......................................................................... 3834
Principles for the detection of extraneous viruses in Pyridostigmine bromide ........................................................ 3836
immunological veterinary medicinal products using culture Pyridoxine hydrochloride...................................................... 3837
methods (2.6.37.).................................................................... 267 Pyrimethamine ....................................................................... 3838
Probenecid............................................................................... 3800 Pyrogens (2.6.8.) ....................................................................... 215
Procainamide hydrochloride................................................. 3802 Pyrophosphate (sodium) decahydrate for radiopharmaceutical
Procaine benzylpenicillin monohydrate .............................. 2075 preparations .......................................................................... 1312
Procaine hydrochloride.......................................................... 3802 Pyrrolidone.............................................................................. 3839
Procaine penicillin G monohydrate ..................................... 2075 Pyrrolizidine alkaloids, contaminant (2.8.26.)...................... 335
Process analytical technology (5.25.) ..................................... 897
Process control, statistical, multivariate (5.28.) ......... 11.1-4579 Q
Prochlorperazine maleate ...................................................... 3803 Quality control of vaccines, substitution of in vivo method(s)
Products of fermentation......................................................... 941 by in vitro method(s) for the (5.2.14.) ................................. 716
Products of recombinant DNA technology........................... 947

Quality of non-sterile pharmaceutical preparations and Red peony root........................................................................ 1662

substances for pharmaceutical use, microbiological Red poppy petals..................................................................... 1691
(5.1.4.) ...................................................................................... 657 Reference standards (5.12.) ..................................................... 809
Quantification and characterisation of residual host-cell DNA Refractive index (2.2.6.) ............................................................. 31
(2.6.35.) .................................................................................... 260 Regorafenib monohydrate ..................................................... 3870
Quetiapine fumarate .............................................................. 3843 Regorafenib tablets ........................................................ 11.1-4740
Quillaia bark............................................................................ 1688 Rehmannia root ...................................................................... 1691
Quinapril hydrochloride........................................................ 3845 Relative density (2.2.5.).............................................................. 31
Quinidine sulfate .................................................................... 3847 Remifentanil hydrochloride .................................................. 3874
Quinine hydrochloride dihydrate................................ 11.1-4735 Repaglinide.............................................................................. 3877
Quinine sulfate........................................................................ 3850 Reserpine ................................................................................. 3878
Residual pertussis toxin (2.6.33.)............................................ 254
R Residual solvents (5.4.) ............................................................ 753
Rabbit haemorrhagic disease vaccine (inactivated) ........... 1209 Residual solvents, identification and control of (2.4.24.) .... 162
Rabeprazole sodium ............................................................... 3855 Residue on evaporation of essential oils (2.8.9.)................... 322
Rabeprazole sodium hydrate................................................. 3856 Residues, pesticide (2.8.13.)..................................................... 324
Rabies immunoglobulin, human .......................................... 3010 Resistance to crushing of tablets (2.9.8.) ............................... 360
Rabies vaccine for human use prepared in cell cultures.... 1094 Resorcinol ................................................................................ 3879
Rabies vaccine (inactivated) for veterinary use ......... 11.1-4609 Respiratory syncytial virus vaccine (live), bovine .............. 1137
Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1213 Restharrow root ...................................................................... 1693
Racecadotril............................................................................. 3858 Rhatany root............................................................................ 1694
Racementhol............................................................................ 3343 Rhatany tincture ..................................................................... 1695
Racemic camphor ................................................................... 2189 Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1183
Racemic ephedrine hydrochloride ....................................... 2644 Rhinotracheitis vaccine (inactivated), viral, feline ............. 1176
Racemic menthol .................................................................... 3343 Rhinotracheitis vaccine (live), bovine, infectious............... 1184
Racephedrine hydrochloride................................................. 2644 Rhinotracheitis vaccine (live), infectious, turkey ............... 1224
Raclopride ([11C]methoxy) injection........................... 11.1-4619 Rhinotracheitis vaccine (live), viral, feline .......................... 1177
Radioactivity, detection and measurement of (2.2.66.) ....... 129 Rhizome and root, notopterygium....................................... 1640
Radionuclides, table of physical characteristics (5.7.).......... 781 Rhubarb .......................................................................... 11.1-4633
Radiopharmaceutical preparations ............................. 11.1-4587 Rhubarb dry extract, standardised .............................. 11.1-4635
Radiopharmaceutical preparations, chemical precursors Ribavirin .................................................................................. 3880
for ............................................................................................. 920 Riboflavin................................................................................. 3881
Radiopharmaceutical preparations, tetrabutylammonium in Riboflavin sodium phosphate hydrate ........................ 11.2-4939
(2.4.33.) .................................................................................... 175 Ribose in polysaccharide vaccines (2.5.31.) .......................... 190
Radiopharmaceuticals, extemporaneous preparation of Ribwort plantain ..................................................................... 1696
(5.19.) ....................................................................................... 849 Rice starch ............................................................................... 3884
Raloxifene hydrochloride ...................................................... 3859 Rifabutin .................................................................................. 3885
Raltegravir chewable tablets .................................................. 3862 Rifampicin ............................................................................... 3887
Raltegravir potassium ................................................... 11.1-4739 Rifamycin sodium................................................................... 3888
Raltegravir tablets ................................................................... 3864 Rifaximin ........................................................................ 11.1-4743
Raman spectroscopy (2.2.48.) ................................................. 101 Rilmenidine dihydrogen phosphate ..................................... 3891
Ramipril ................................................................................... 3866 Riociguat.................................................................................. 3892
Ramon assay, flocculation value (Lf) of diphtheria and tetanus Riociguat tablets...................................................................... 3894
toxins and toxoids (2.7.27.) ................................................... 310 Risedronate sodium 2.5-hydrate.................................. 11.1-4744
Ranitidine hydrochloride....................................................... 3868 Risperidone ............................................................................. 3897
Rapeseed oil, refined .............................................................. 3870 Ritonavir .................................................................................. 3899
Raspberry leaf ......................................................................... 1689 Rivaroxaban............................................................................. 3902
Raw materials of biological origin for the production of Rivaroxaban tablets ................................................................ 3904
cell-based and gene therapy medicinal products (5.2.12.).. 712 Rivastigmine............................................................................ 3906
Reagents (4.).............................................................................. 507 Rivastigmine hydrogen tartrate ............................................ 3907
Reagents (4.1.1.)........................................................................ 507 Rizatriptan benzoate .............................................................. 3909
Reagents (4.1.1.)............................................................. 11.1-4535 Rocuronium bromide............................................................. 3910
Reagents (4.1.1.)............................................................. 11.2-4839 Rolling ball (automatic) and falling ball viscometer methods
Reagents, standard solutions, buffer solutions (4.1.) ........... 507 (2.2.49.) .................................................................................... 104
Recombinant DNA technology, products of......................... 947 Roman chamomile flower...................................................... 1456
Recombinant factor C, test for bacterial endotoxins using Ropinirole hydrochloride ...................................................... 3912
(2.6.32.) .................................................................................... 252 Ropivacaine hydrochloride monohydrate ........................... 3914
Recombinant vectors ............................................................... 815 Roselle ...................................................................................... 1698
Recommendations on dissolution testing (5.17.1.) .............. 837 Rosemary leaf.......................................................................... 1699
Recommendations on methods for dosage forms testing Rosemary oil ........................................................................... 1700
(5.17.) ....................................................................................... 837 Rosuvastatin calcium..................................................... 11.1-4746
Recommendations on testing of particulate contamination : Rosuvastatin tablets................................................................ 3919
visible particles (5.17.2.) ........................................................ 839 Rotating viscometer method - viscosity (2.2.10.) ................... 33
Rectal and vaginal dosage forms, solid, disintegration test for Rotation, optical (2.2.7.) ............................................................ 31
(2.9.2.) ...................................................................................... 347 Rotavirus diarrhoea vaccine (inactivated), calf .................. 1142
Rectal capsules ........................................................................ 1000 Rotavirus vaccine (live, oral)................................................. 1097
Rectal foams ............................................................................ 1001 Rotigotine ................................................................................ 3921
Rectal preparations................................................................. 1000 Round amomum fruit ............................................................ 1701
Rectal preparations, semi-solid............................................. 1001 Roxithromycin ........................................................................ 3923
Rectal solutions, emulsions and suspensions...................... 1001 RRR-α-Tocopherol.................................................................. 4238
Rectal solutions or suspensions, powders and tablets for.. 1001 RRR-α-Tocopheryl acetate..................................................... 4240
Rectal tampons........................................................................ 1001 RRR-α-Tocopheryl hydrogen succinate ............................... 4244
Rubber closures for containers for aqueous parenteral Senna pods .............................................................................. 1725
preparations, for powders and for freeze-dried powders Separation techniques, chromatographic (2.2.46.) ................. 86
(3.2.9.) ........................................................................... 11.1-4529 Serine........................................................................................ 3948
Rubella immunoglobulin, human ........................................ 3011 Serratula coronata herb................................................. 11.2-4859
Rubella, measles and mumps vaccine (live) ........................ 1070 Sertaconazole nitrate .............................................................. 3950
Rubella, measles, mumps and varicella vaccine (live)........ 1071 Sertraline hydrochloride........................................................ 3951
Rubella vaccine (live) ............................................................. 1099 Sesame oil, refined.................................................................. 3953
Ruminant colibacillosis vaccine (inactivated), neonatal.... 1196 Sets for the transfusion of blood and blood components
Rupatadine fumarate .............................................................. 3926 (3.3.7.) ...................................................................................... 501
Rutoside trihydrate ................................................................. 3927 Sevoflurane ..................................................................... 11.1-4751
Shampoos .................................................................................. 980
S Shear cell methods, powder flow properties by (2.9.49.)..... 434
Saccharin.................................................................................. 3931 Shellac ..................................................................................... 3956
Saccharin sodium ................................................................... 3932 Shepherd’s purse ..................................................................... 1729
Safety, viral (5.1.7.) ................................................................... 667 Shingles (herpes zoster) vaccine (live) ................................. 1100
Safflower flower ...................................................................... 1703 SI (International System) units (1.) ............................................ 3
Safflower oil, refined............................................................... 3933 Sialic acid in polysaccharide vaccines (2.5.23.)..................... 186
Saffron for homoeopathic preparations............................... 1822 Siam benzoin........................................................................... 1410
Sage leaf (Salvia officinalis) ................................................... 1704 Siam benzoin tincture ............................................................ 1411
Sage leaf, three-lobed ............................................................. 1705 Sieve test (2.9.12.) ..................................................................... 366
Sage oil, Spanish...................................................................... 1734 Sieves (2.1.4.)............................................................................... 18
Sage tincture ............................................................................ 1706 Sieving, analytical, particle-size distribution estimation by
Salbutamol ............................................................................... 3933 (2.9.38.) ......................................................................... 11.1-4523
Salbutamol sulfate................................................................... 3936 Sildenafil citrate ...................................................................... 3957
Salicylic acid ............................................................................ 3938 Silica, colloidal anhydrous..................................................... 3959
Salmeterol xinafoate ...................................................... 11.2-4943 Silica, colloidal hydrated........................................................ 3959
Salmon oil, farmed ................................................................. 3941 Silica, dental type.................................................................... 3960
Salmonella Enteritidis vaccine (inactivated) for chickens.. 1214 Silica, hydrophobic colloidal ................................................. 3961
Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1215 Silicate, aluminium magnesium............................................ 1921
Salmonella Typhimurium vaccine (inactivated) for Silicate, aluminium sodium................................................... 1925
chickens ................................................................................. 1217 Silicone elastomer for closures and tubing (3.1.9.)............... 462
Salmonella Typhimurium vaccine (live, oral) for Silicone oil used as a lubricant (3.1.8.)................................... 462
chickens ................................................................................. 1218 Silk suture, sterile, braided, in distributor for veterinary
Salmonids, infectious pancreatic necrosis vaccine (inactivated use........................................................................................... 1351
oil-adjuvanted, injectable) for ............................................. 1187 Silver, colloidal........................................................................ 3961
Salvia miltiorrhiza root and rhizome................................... 1707 Silver nitrate ............................................................................ 3962
Sanguinaria for homoeopathic preparations....................... 1842 Simeticone ............................................................................... 3962
Sanguisorba root..................................................................... 1709 Simvastatin .............................................................................. 3963
Saponification value (2.5.6.) .................................................... 181 Single-dose preparations, uniformity of content (2.9.6.)..... 358
Saposhnikovia root ........................................................ 11.1-4636 Single-dose preparations, uniformity of mass
Saquinavir mesilate................................................................. 3943 (2.9.5.) ........................................................................... 11.1-4523
Saw palmetto extract .............................................................. 1710 Sintered-glass filters (2.1.2.) ...................................................... 17
Saw palmetto fruit .................................................................. 1712 Sitagliptin phosphate monohydrate ..................................... 3966
Saxagliptin monohydrate.............................................. 11.2-4944 Sitagliptin tablets .................................................................... 3967
Scanning electron microscopy (2.9.52.)................................. 437 Size-exclusion chromatography (2.2.30.).................... 11.1-4505
Schisandra fruit....................................................................... 1714 (S)-Lactic acid ......................................................................... 3191
Scopolamine ............................................................................ 3049 Smallpox vaccine (live) .......................................................... 1102
Scopolamine butylbromide ................................................... 3050 Sodium acetate ([1-11C]) injection............................... 11.1-4620
Scopolamine hydrobromide .................................................. 3052 Sodium acetate trihydrate...................................................... 3969
Scrophularia root .................................................................... 1716 Sodium alendronate trihydrate ............................................. 3969
Sea bass, vibriosis vaccine (inactivated) for ........................ 1228 Sodium alginate ...................................................................... 3971
Seed, pumpkin ............................................................... 11.2-4858 Sodium aluminium silicate.................................................... 1925
Selamectin for veterinary use................................................ 3945 Sodium amidotrizoate............................................................ 3971
Selegiline hydrochloride ........................................................ 3946 Sodium aminosalicylate dihydrate ....................................... 3972
Selenium disulfide .................................................................. 3948 Sodium ascorbate .......................................................... 11.2-4945
Selenium for homoeopathic preparations ........................... 1844 Sodium aurothiomalate ......................................................... 3975
Selfheal fruit-spike, common ................................................ 1474 Sodium benzoate .................................................................... 3976
Semi-micro determination of water (2.5.12.)........................ 183 Sodium bromide ..................................................................... 3977
Semi-solid ear preparations..................................................... 969 Sodium calcium edetate......................................................... 3978
Semi-solid eye preparations .................................................... 971 Sodium calcium pentetate hydrate for radiopharmaceutical
Semi-solid intrauterine preparations ..................................... 975 preparations .......................................................................... 1290
Semi-solid nasal preparations ................................................. 984 Sodium caprylate .................................................................... 3979
Semi-solid oromucosal preparations...................................... 986 Sodium carbonate................................................................... 3980
Semi-solid preparations for cutaneous application ............ 1001 Sodium carbonate decahydrate............................................. 3980
Semi-solid preparations for oral use, veterinary ................ 1009 Sodium carbonate monohydrate .......................................... 3981
Semi-solid rectal preparations .............................................. 1001 Sodium carboxymethylcellulose ........................................... 2213
Semi-solid vaginal preparations .................................. 11.1-4594 Sodium carboxymethylcellulose, cross-linked.................... 2436
Senega root .............................................................................. 1717 Sodium carboxymethylcellulose, low-substituted .............. 2214
Senna fruit dry aqueous extract, standardised.................... 1719 Sodium cetostearyl sulfate..................................................... 3981
Senna fruit dry hydroalcoholic extract, standardised ........ 1720 Sodium chloride...................................................................... 3983
Senna leaflet............................................................................. 1721 Sodium chromate (51Cr) sterile solution.............................. 1296
Senna leaflet dry extract, standardised ................................ 1723 Sodium citrate ......................................................................... 3984
Sodium cromoglicate ............................................................. 3985

Sodium cyclamate................................................................... 3986 Solids, density of (2.2.42.).......................................................... 82

Sodium dihydrogen phosphate dihydrate ........................... 3987 Solids, gas pycnometric density of (2.9.23.) .......................... 386
Sodium disulfite ...................................................................... 4001 Solids (porous) including powders, wettability of (2.9.45.).. 429
Sodium ethyl parahydroxybenzoate..................................... 3988 Solifenacin succinate .............................................................. 4021
Sodium fluoride ...................................................................... 3989 Solubility in alcohol of essential oils (2.8.10.)....................... 323
Sodium fluoride (18F) injection ............................................. 1297 Soluble tablets ......................................................................... 1006
Sodium fusidate ...................................................................... 3990 Solution calorimetry and microcalorimetry, characterisation
Sodium glycerophosphate, hydrated .................................... 3992 of crystalline solids by (2.2.61.) ............................................ 124
Sodium hyaluronate ............................................................... 3993 Solutions, emulsions and suspensions, oral .......................... 981
Sodium hydrogen carbonate ................................................. 3995 Solutions for haemodialysis................................................... 2936
Sodium hydroxide .................................................................. 3996 Solutions for haemodialysis, concentrated, water for
Sodium iodide......................................................................... 3996 diluting................................................................................... 2935
Sodium iodide (123I) injection ............................................... 1298 Solutions for haemofiltration and haemodiafiltration ....... 2941
Sodium iodide (123I) solution for radiolabelling ................. 1299 Solutions for organ preservation .......................................... 4023
Sodium iodide (131I) capsules for diagnostic use ................ 1299 Solutions for peritoneal dialysis............................................ 3671
Sodium iodide (131I) capsules for therapeutic use............... 1300 Solutions, intravesical............................................................... 977
Sodium iodide (131I) solution ................................................ 1301 Solutions, oromucosal.............................................................. 986
Sodium iodide (131I) solution for radiolabelling ................. 1302 Solutions, rectal....................................................................... 1001
Sodium iodohippurate (123I) injection ................................. 1303 Solutions, suspensions, intrauterine....................................... 975
Sodium iodohippurate (131I) injection ................................. 1304 Solutions, vaginal........................................................... 11.1-4594
Sodium iodohippurate dihydrate for radiopharmaceutical Solvents, residual (5.4.) ............................................................ 753
preparations .......................................................................... 1305 Solvents, residual, identification and control of (2.4.24.) .... 162
Sodium lactate solution ......................................................... 3997 Somatostatin............................................................................ 4024
Sodium laurilsulfate ............................................................... 3998 Somatropin ..................................................................... 11.2-4950
Sodium lauroylsarcosinate for external use......................... 3999 Somatropin concentrated solution .............................. 11.2-4952
Sodium metabisulfite ............................................................. 4001 Somatropin injection..................................................... 11.2-4954
Sodium methyl parahydroxybenzoate ................................. 4001 Somatropin powder for injection ................................ 11.2-4955
Sodium molybdate (99Mo) solution (fission) ...................... 1305 Sophora flower ........................................................................ 1731
Sodium molybdate dihydrate................................................ 4003 Sophora flower-bud................................................................ 1732
Sodium nitrite ......................................................................... 4003 Sorafenib tablets...................................................................... 4035
Sodium nitroprusside............................................................. 4004 Sorafenib tosilate .................................................................... 4033
Sodium perborate, hydrated.................................................. 4004 Sorbic acid ............................................................................... 4036
Sodium pertechnetate (99mTc) injection (accelerator- Sorbitan laurate....................................................................... 4037
produced) .............................................................................. 1307 Sorbitan oleate......................................................................... 4037
Sodium pertechnetate (99mTc) injection (fission) ............... 1309 Sorbitan palmitate .................................................................. 4038
Sodium pertechnetate (99mTc) injection (non-fission) ....... 1310 Sorbitan sesquioleate.............................................................. 4038
Sodium phenylbutyrate.......................................................... 4005 Sorbitan stearate ..................................................................... 4039
Sodium phosphate (32P) injection......................................... 1311 Sorbitan trioleate .................................................................... 4039
Sodium picosulfate ................................................................. 4006 Sorbitol..................................................................................... 4040
Sodium polystyrene sulfonate ............................................... 4007 Sorbitol, liquid (crystallising) ............................................... 4042
Sodium propionate ................................................................. 4008 Sorbitol, liquid (non-crystallising) ....................................... 4042
Sodium propyl parahydroxybenzoate .................................. 4009 Sorbitol, liquid, partially dehydrated ................................... 4043
Sodium pyrophosphate decahydrate for radiopharmaceutical Sorption-desorption isotherms and water activity,
preparations .......................................................................... 1312 determination of (water-solid interactions) (2.9.39.)......... 417
Sodium risedronate 2.5-hydrate .................................. 11.1-4744 Sotalol hydrochloride............................................................. 4044
Sodium salicylate .................................................................... 4011 Soya phospholipids for injection .......................................... 4045
Sodium selenite....................................................................... 4011 Soya-bean oil, hydrogenated ................................................. 4047
Sodium selenite pentahydrate ............................................... 4012 Soya-bean oil, refined............................................................. 4047
Sodium (S)-lactate solution................................................... 3997 Spanish sage oil ....................................................................... 1734
Sodium starch glycolate (type A)................................. 11.2-4947 Specific surface area by air permeability (2.9.14.) ................ 366
Sodium starch glycolate (type B) ................................. 11.2-4948 Specific surface area by gas adsorption (2.9.26.) .................. 392
Sodium starch glycolate (type C).......................................... 4015 Spectinomycin dihydrochloride pentahydrate.................... 4048
Sodium stearate....................................................................... 4016 Spectinomycin sulfate tetrahydrate for veterinary use....... 4050
Sodium stearyl fumarate........................................................ 4017 Spectrometry, atomic absorption (2.2.23.).............................. 43
Sodium sulfate, anhydrous .................................................... 4017 Spectrometry, atomic emission (2.2.22.) ................................. 42
Sodium sulfate decahydrate................................................... 4018 Spectrometry, mass (2.2.43.) ..................................................... 83
Sodium sulfite ......................................................................... 4019 Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 63
Sodium sulfite heptahydrate.................................................. 4019 Spectrometry, X-ray fluorescence (2.2.37.) ............................. 71
Sodium tetrachloroaurate dihydrate for homoeopathic Spectrophotometry, infrared absorption (2.2.24.) ................. 45
preparations .......................................................................... 1815 Spectrophotometry, ultraviolet and visible absorption
Sodium thiosulfate.................................................................. 4020 (2.2.25.) ...................................................................................... 48
Sodium valproate.................................................................... 4020 Spectroscopy, near-infrared (2.2.40.)....................................... 76
Soft capsules .............................................................................. 966 Spectroscopy, Raman (2.2.48.)................................................ 101
Soft extracts ............................................................................... 926 SPF chicken flocks for the production and quality control of
Softening time determination of lipophilic suppositories vaccines (5.2.2.)............................................................ 11.1-4539
(2.9.22.) .................................................................................... 385 Spheroids and granules, friability of (2.9.41.) ....................... 423
Solid dosage forms, dissolution test for (2.9.3.).................... 348 Spike lavender oil.................................................................... 1735
Solid dosage forms, recommendations on dissolution testing Spiramycin............................................................................... 4052
of (5.17.1.)................................................................................ 837 Spirapril hydrochloride monohydrate ................................. 4055
Solid rectal and vaginal dosage forms, disintegration test for Spironolactone ........................................................................ 4056
(2.9.2.) ...................................................................................... 347 Spot-on preparations.............................................................. 1008
Solids by mercury porosimetry, porosity and pore-size Sprays, ear.................................................................................. 968
distribution of (2.9.32.).......................................................... 400 Sprays, nasal .............................................................................. 983
Sprays, oromucosal................................................................... 986 Sublingual sprays ...................................................................... 986

Sprays, veterinary ................................................................... 1008 Sublingual tablets and buccal tablets...................................... 987
Squalane................................................................................... 4058 Substances for pharmaceutical use ......................................... 949
Squalene................................................................................... 4059 Substances for pharmaceutical use, control of impurities in
St. John’s wort.......................................................................... 1736 (5.10.) ....................................................................................... 799
St. John’s wort dry extract, quantified.................................. 1738 Substitution of in vivo method(s) by in vitro method(s) for the
Standard solutions for limit tests (4.1.2.)............................... 628 quality control of vaccines (5.2.14.) ..................................... 716
Standards, reference (5.12.) ..................................................... 809 Sub-visible particles in non-injectable liquid preparations,
Stannous chloride dihydrate.................................................. 4060 particulate contamination (2.9.53.)...................................... 441
Stanozolol ................................................................................ 4060 Sub-visible particles, particulate contamination (2.9.19.) ... 382
Staphysagria for homoeopathic preparations ..................... 1844 Sucralfate ................................................................................. 4078
Star anise.................................................................................. 1739 Sucralose .................................................................................. 4079
Star anise oil ............................................................................ 1741 Sucrose ..................................................................................... 4081
Starch glycolate (type A), sodium................................ 11.2-4947 Sucrose, liquid......................................................................... 4082
Starch glycolate (type B), sodium ................................ 11.2-4948 Sucrose monopalmitate.......................................................... 4084
Starch glycolate (type C), sodium......................................... 4015 Sucrose stearate....................................................................... 4085
Starch, hydroxypropyl ................................................... 11.2-4957 Sufentanil ................................................................................. 4087
Starch, hydroxypropyl, pregelatinised......................... 11.2-4959 Sufentanil citrate ..................................................................... 4088
Starch, maize ........................................................................... 3311 Sugar spheres........................................................................... 4089
Starch, pea ............................................................................... 3645 Sugars, lead in (2.4.10.) ............................................................ 152
Starch, potato .......................................................................... 3771 Sulbactam sodium .................................................................. 4090
Starch, pregelatinised ............................................................. 4065 Sulfacetamide sodium ............................................................ 4092
Starch, rice ............................................................................... 3884 Sulfadiazine ............................................................................. 4093
Starch, wheat ........................................................................... 4393 Sulfadimethoxine.................................................................... 4094
Starches, hydroxyethyl ........................................................... 4066 Sulfadimethoxine sodium for veterinary use ...................... 4096
Starflower (borage) oil, refined ............................................. 2111 Sulfadimidine .......................................................................... 4097
Statistical analysis of results of biological assays and tests Sulfadoxine .............................................................................. 4099
(5.3.) ......................................................................................... 721 Sulfafurazole............................................................................ 4100
Statistical process control, multivariate (5.28.) .......... 11.1-4579 Sulfaguanidine ........................................................................ 4100
Stavudine ................................................................................. 4070 Sulfamerazine.......................................................................... 4101
Stearic acid...................................................................... 11.2-4961 Sulfamethizole......................................................................... 4102
Stearoyl macrogolglycerides .................................................. 4074 Sulfamethoxazole.................................................................... 4103
Stearyl alcohol ......................................................................... 4075 Sulfamethoxypyridazine for veterinary use......................... 4105
Stem cells, human haematopoietic ....................................... 2995 Sulfanilamide........................................................................... 4106
Stephania root, fourstamen ................................................... 1515 Sulfasalazine ............................................................................ 4106
Sterile braided silk suture in distributor for veterinary Sulfated ash (2.4.14.) ................................................................ 152
use........................................................................................... 1351 Sulfates (2.4.13.)........................................................................ 152
Sterile catgut............................................................................ 1339 Sulfathiazole ............................................................................ 4108
Sterile catgut in distributor for veterinary use.................... 1349 Sulfinpyrazone......................................................................... 4109
Sterile containers of plasticised poly(vinyl chloride) for human Sulfobutylbetadex sodium ..................................................... 4110
blood containing anticoagulant solution (3.3.6.) ............... 500 Sulfur ....................................................................................... 4113
Sterile linen thread in distributor for veterinary use ......... 1350 Sulfur dioxide (2.5.29.)............................................................. 189
Sterile non-absorbable strands in distributor for veterinary Sulfur for homoeopathic preparations................................. 1847
use........................................................................................... 1351 Sulfuric acid............................................................................. 4114
Sterile non-absorbable sutures .............................................. 1340 Sulindac.................................................................................... 4114
Sterile plastic containers for human blood and blood Sulpiride................................................................................... 4115
components (3.3.4.)................................................................ 497 Sultamicillin ............................................................................ 4117
Sterile polyamide suture in distributor for veterinary use.. 1350 Sultamicillin tosilate dihydrate ............................................. 4119
Sterile poly(ethylene terephthalate) suture in distributor for Sumatra benzoin ..................................................................... 1411
veterinary use........................................................................ 1351 Sumatra benzoin tincture ...................................................... 1412
Sterile products, biological indicators and related microbial Sumatriptan succinate............................................................ 4121
preparations used in the manufacture of (5.1.2.) ............... 652 Sunflower oil, refined ............................................................. 4123
Sterile products, methods of preparation of (5.1.1.) ............ 649 Supercritical fluid chromatography (2.2.45.) ............. 11.1-4505
Sterile single-use plastic syringes (3.3.8.) .............................. 503 Suppositories ........................................................................... 1000
Sterile synthetic absorbable braided sutures ....................... 1343 Suppositories, lipophilic, softening time determination
Sterile synthetic absorbable monofilament sutures ............ 1345 (2.9.22.) .................................................................................... 385
Sterility (2.6.1.).......................................................................... 207 Suspensions, intravesical.......................................................... 977
Sterility, guidelines for using the test for (5.1.9.).................. 669 Suspensions, oromucosal ......................................................... 986
Sterols in fatty oils (2.4.23.) ..................................................... 160 Suspensions, rectal.................................................................. 1001
Sticks ........................................................................................ 1003 Suspensions, solutions and emulsions, oral .......................... 981
Sticks, intrauterine.................................................................... 975 Suspensions, solutions, intrauterine....................................... 975
Sticks, nasal ............................................................................... 984 Suspensions, vaginal...................................................... 11.1-4594
Stomata and stomatal index (2.8.3.) ....................................... 321 Sutures for human use : introduction................................... 1339
Stramonium for homoeopathic preparations...................... 1846 Sutures, sterile non-absorbable ............................................. 1340
Stramonium leaf ..................................................................... 1743 Sutures, sterile synthetic absorbable braided ..................... 1343
Stramonium, prepared ........................................................... 1744 Sutures, sterile synthetic absorbable monofilament .......... 1345
Strands, sterile non-absorbable, in distributor for veterinary Suxamethonium chloride ...................................................... 4123
use .......................................................................................... 1351 Suxibuzone .............................................................................. 4124
Streptokinase concentrated solution .................................... 4075 Sweet fennel............................................................................. 1509
Streptomycin sulfate ............................................................... 4077 Sweet orange oil ...................................................................... 1745
Strontium (89Sr) chloride injection....................................... 1312 Swelling index (2.8.4.) .............................................................. 322
Strychnos ignatii for homoeopathic preparations.............. 1833 Swine erysipelas vaccine (inactivated) ................................. 1221
Subdivision of tablets ............................................................. 1004

Swine-fever vaccine (live, prepared in cell cultures), Telmisartan.............................................................................. 4146

classical .................................................................................. 1221 Temazepam.............................................................................. 4148
Symbols and abbreviations (1.)................................................... 3 Temozolomide......................................................................... 4149
Synthetic absorbable braided sutures, sterile ...................... 1343 Tenosynovitis vaccine (live), viral, avian .................... 11.1-4602
Synthetic absorbable monofilament sutures, sterile ........... 1345 Tenoxicam ............................................................................... 4150
Syringes, plastic, sterile single-use (3.3.8.) ............................ 503 Terazosin hydrochloride dihydrate ...................................... 4152
Syrups......................................................................................... 981 Terbinafine hydrochloride ..................................................... 4154
Systems, vaginal delivery .............................................. 11.1-4594 Terbutaline sulfate .................................................................. 4155
Szechwan lovage rhizome ...................................................... 1747 Terconazole.............................................................................. 4156
Terfenadine.............................................................................. 4158
T Teriflunomide................................................................. 11.1-4755
Table of physical characteristics of radionuclides mentioned in Teriflunomide tablets ............................................................. 4160
the European Pharmacopoeia (5.7.)..................................... 781 Teriparatide ............................................................................. 4162
Tablets ...................................................................................... 1004 Terlipressin .............................................................................. 4164
Tablets and capsules, disintegration of (2.9.1.) ..................... 345 Terminology used in monographs on biological products
Tablets and powders for rectal solutions or suspensions... 1001 (5.2.1.) ...................................................................................... 679
Tablets and powders for vaginal solutions or Terpin monohydrate............................................................... 4166
suspensions................................................................... 11.1-4594 Test for anticomplementary activity of immunoglobulin
Tablets, buccal ........................................................................... 987 (2.6.17.) ......................................................................... 11.1-4509
Tablets, buccal, mucoadhesive ................................................ 987 Test for anti-D antibodies in human immunoglobulin
Tablets, chewable .................................................................... 1006 (2.6.26.) .................................................................................... 240
Tablets, coated ......................................................................... 1005 Test for aristolochic acids in herbal drugs (2.8.21) .............. 330
Tablets, dispersible.................................................................. 1006 Test for bacterial endotoxins using recombinant factor C
Tablets, effervescent................................................................ 1005 (2.6.32.) .................................................................................... 252
Tablets for intrauterine solutions and suspensions .............. 975 Test for extractable volume of parenteral preparations
Tablets, gastro-resistant.......................................................... 1005 (2.9.17.) .................................................................................... 369
Tablets, intrauterine.................................................................. 975 Test for Fc function of immunoglobulin (2.7.9.) .................. 295
Tablets, modified-release ....................................................... 1005 Test for methanol and 2-propanol (2.9.11.) .......................... 364
Tablets, orodispersible............................................................ 1006 Test for neurovirulence of live virus vaccines (2.6.18.)........ 234
Tablets, resistance to crushing (2.9.8.) ................................... 360 Test for specified micro-organisms (microbiological
Tablets, soluble ........................................................................ 1006 examination of non-sterile products) (2.6.13.) ................... 221
Tablets, subdivision of............................................................ 1004 Testosterone............................................................................. 4167
Tablets, sublingual .................................................................... 987 Testosterone decanoate .......................................................... 4169
Tablets, uncoated .................................................................... 1005 Testosterone enantate ............................................................. 4170
Tablets, uncoated, friability of (2.9.7.) ................................... 359 Testosterone isocaproate ........................................................ 4172
Tablets, vaginal............................................................... 11.1-4593 Testosterone propionate......................................................... 4173
Tacalcitol monohydrate.......................................................... 4129 Tests for extraneous agents in viral vaccines for human use
Tacrolimus monohydrate....................................................... 4130 (2.6.16.) .................................................................................... 230
Tadalafil.................................................................................... 4133 Tests for specified micro-organisms (microbiological
Talc ........................................................................................... 4135 examination of live biotherapeutic products) (2.6.38.)...... 267
Tamoxifen citrate .................................................................... 4137 Tetanus and diphtheria toxins and toxoids, flocculation value
Tampons, ear ............................................................................. 970 (Lf) of, (Ramon assay) (2.7.27.)............................................ 310
Tampons, medicated ............................................................. 1006 Tetanus and diphtheria vaccine (adsorbed) ........................ 1018
Tampons, rectal....................................................................... 1001 Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)
Tampons, vaginal, medicated ....................................... 11.1-4594 content).................................................................................. 1019
Tamsulosin hydrochloride..................................................... 4139 Tetanus antitoxin for human use .......................................... 1237
Tannic acid .............................................................................. 4140 Tetanus antitoxin for veterinary use..................................... 1241
Tannins in herbal drugs (2.8.14.)............................................ 326 Tetanus, diphtheria and pertussis (acellular, component)
Tapentadol hydrochloride ..................................................... 4141 vaccine (adsorbed) ............................................................... 1021
Tapped density and bulk density of powders (2.9.34.)......... 407 Tetanus, diphtheria and pertussis (acellular, component)
Tartaric acid............................................................................. 4142 vaccine (adsorbed, reduced antigen(s) content)............... 1022
Tea tree oil ............................................................................... 1748 Tetanus, diphtheria and pertussis (whole cell) vaccine
Teat dips................................................................................... 1009 (adsorbed) ............................................................................. 1023
Teat sprays ............................................................................... 1009 Tetanus, diphtheria and poliomyelitis (inactivated) vaccine
Technetium (99mTc) bicisate injection .................................. 1313 (adsorbed, reduced antigen(s) content)............................. 1025
Technetium (99mTc) colloidal rhenium sulfide injection ... 1314 Tetanus, diphtheria, pertussis (acellular, component) and
Technetium (99mTc) colloidal tin injection .......................... 1315 haemophilus type b conjugate vaccine (adsorbed)........... 1026
Technetium (99mTc) etifenin injection.................................. 1316 Tetanus, diphtheria, pertussis (acellular, component) and
Technetium (99mTc) exametazime injection ........................ 1317 poliomyelitis (inactivated) vaccine (adsorbed)................. 1029
Technetium (99mTc) gluconate injection .............................. 1318 Tetanus, diphtheria, pertussis (acellular, component) and
Technetium (99mTc) human albumin injection ................... 1319 poliomyelitis (inactivated) vaccine (adsorbed, reduced
Technetium (99mTc) macrosalb injection ............................. 1320 antigen(s) content) ............................................................... 1031
Technetium (99mTc) mebrofenin injection ........................... 1321 Tetanus, diphtheria, pertussis (acellular, component),
Technetium (99mTc) medronate injection ............................ 1322 hepatitis B (rDNA), poliomyelitis (inactivated) and
Technetium (99mTc) mertiatide injection ............................. 1323 haemophilus type b conjugate vaccine (adsorbed)........... 1033
Technetium (99mTc) microspheres injection ........................ 1324 Tetanus, diphtheria, pertussis (acellular, component),
Technetium (99mTc) oxidronate injection ............................ 1325 poliomyelitis (inactivated) and haemophilus type b conjugate
Technetium (99mTc) pentetate injection ............................... 1326 vaccine (adsorbed) ............................................................... 1035
Technetium (99mTc) sestamibi injection ............................... 1327 Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis
Technetium (99mTc) succimer injection................................ 1329 (inactivated) vaccine (adsorbed) ........................................ 1037
Technetium (99mTc) tin pyrophosphate injection ............... 1329 Tetanus immunoglobulin, human ........................................ 3011
Teicoplanin .............................................................................. 4143 Tetanus vaccine (adsorbed) ................................................... 1106
Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 291
Tetanus vaccine for veterinary use ....................................... 1223 Tocopheryl acetate, all-rac-α- ............................................... 4239
Tetrabutylammonium in radiopharmaceutical preparations α-Tocopheryl acetate concentrate (powder form).............. 4241
(2.4.33.) .................................................................................... 175 Tocopheryl acetate, RRR-α-................................................... 4240
Tetracaine ................................................................................ 4175 Tocopheryl hydrogen succinate, DL-α- ................................ 4242
Tetracaine hydrochloride....................................................... 4176 Tocopheryl hydrogen succinate, RRR-α- ............................. 4244
Tetracosactide.......................................................................... 4177 Tolbutamide............................................................................. 4246
Tetracycline ............................................................................. 4178 Tolfenamic acid ....................................................................... 4247
Tetracycline hydrochloride.................................................... 4179 Tolnaftate ................................................................................. 4248
Tetra-O-acetyl-mannose triflate for radiopharmaceutical Tolterodine tartrate................................................................. 4250
preparations .......................................................................... 1331 Tolu balsam ............................................................................. 1757
Tetrazepam .............................................................................. 4181 Toluenesulfonate (methyl, ethyl and isopropyl) in active
Tetryzoline hydrochloride ..................................................... 4182 substances (2.5.40.)................................................................. 197
Thallous (201Tl) chloride injection ........................................ 1332 Topiramate............................................................................... 4251
Theophylline ........................................................................... 4183 Torasemide .............................................................................. 4253
Theophylline monohydrate ................................................... 4184 Tormentil ................................................................................. 1757
Theophylline-ethylenediamine .................................... 11.1-4756 Tormentil tincture .................................................................. 1758
Theophylline-ethylenediamine hydrate ...................... 11.1-4757 Tosylchloramide sodium ....................................................... 4254
Thermal analysis (2.2.34.).......................................................... 66 Total ash (2.4.16.)...................................................................... 153
Thermogravimetry (2.2.34.)...................................................... 66 Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 174
Thiamazole .............................................................................. 4188 Total organic carbon in water for pharmaceutical use
Thiamine hydrochloride ........................................................ 4189 (2.2.44.) ...................................................................................... 85
Thiamine nitrate ..................................................................... 4191 Total protein (2.5.33.)............................................................... 191
Thiamphenicol ........................................................................ 4192 Toxicodendron quercifolium for homoeopathic
Thin-layer chromatography (2.2.27.) .......................... 11.1-4501 preparations .......................................................................... 1848
Thiocolchicoside crystallised from ethanol ........................ 4193 Traditional Chinese drugs, methods of pretreatment for
Thiocolchicoside hydrate....................................................... 4195 preparing (general information) (5.18.) .............................. 843
Thioctic acid............................................................................ 4198 Traditional Chinese medicine, names of herbal drugs used in
Thiomersal............................................................................... 4199 (5.22.) ............................................................................ 11.1-4573
Thiopental sodium and sodium carbonate ................ 11.2-4965 Tragacanth ............................................................................... 1759
Thioridazine ............................................................................ 4201 Tramadol hydrochloride ........................................................ 4255
Thioridazine hydrochloride .................................................. 4202 Tramazoline hydrochloride monohydrate........................... 4256
Thomson kudzuvine root ...................................................... 1749 Trandolapril............................................................................. 4257
Three-lobed sage leaf ............................................................. 1705 Tranexamic acid...................................................................... 4259
Threonine ................................................................................ 4204 Transdermal patches ................................................................ 990
Thunberg fritillary bulb......................................................... 1750 Trapidil..................................................................................... 4260
Thyme ...................................................................................... 1752 Trazodone hydrochloride ...................................................... 4261
Thyme oil, thymol type.......................................................... 1754 Trehalose dihydrate ................................................................ 4262
Thyme, wild............................................................................. 1777 Tretinoin .................................................................................. 4264
Thymol..................................................................................... 4205 Triacetin ................................................................................... 4265
Thymol type thyme oil........................................................... 1754 Triamcinolone ......................................................................... 4266
Tiabendazole ........................................................................... 4206 Triamcinolone acetonide ....................................................... 4267
Tiamulin for veterinary use................................................... 4207 Triamcinolone hexacetonide ................................................. 4269
Tiamulin hydrogen fumarate for veterinary use................. 4209 Triamterene ............................................................................. 4270
Tianeptine sodium.................................................................. 4212 Tribenoside.............................................................................. 4271
Tiapride hydrochloride .......................................................... 4213 Tributyl acetylcitrate............................................................... 4272
Tiaprofenic acid ...................................................................... 4214 Trichloroacetic acid ................................................................ 4275
Tibolone.......................................................................... 11.1-4759 Triclabendazole for veterinary use ....................................... 4275
Ticagrelor................................................................................. 4217 Triethanolamine...................................................................... 4289
Ticagrelor tablets .................................................................... 4219 Triethyl citrate................................................................ 11.2-4967
Ticarcillin sodium .................................................................. 4220 Trifluoperazine hydrochloride .............................................. 4277
Tick-borne encephalitis vaccine (inactivated) .................... 1107 Trifluridine .............................................................................. 4278
Ticlopidine hydrochloride ..................................................... 4222 Triflusal .................................................................................... 4279
Tigecycline............................................................................... 4223 Triglycerides, medium-chain ................................................ 4280
Tilidine hydrochloride hemihydrate ........................... 11.1-4760 Triglycerides, omega-3-acid .................................................. 3575
Timolol maleate ...................................................................... 4226 Triglycerol diisostearate ......................................................... 4281
Tinctures .................................................................................... 925 Trihexyphenidyl hydrochloride ............................................ 4281
Tinidazole ................................................................................ 4228 Trimebutine maleate .............................................................. 4282
Tinnevelly senna pods............................................................ 1725 Trimeprazine hemitartrate .................................................... 1902
Tinzaparin sodium ................................................................. 4229 Trimetazidine dihydrochloride .................................... 11.1-4761
Tioconazole ............................................................................. 4230 Trimethadione......................................................................... 4285
Tiotropium bromide monohydrate ...................................... 4231 Trimethoprim.......................................................................... 4286
Titanium dioxide ........................................................... 11.2-4966 Trimipramine maleate............................................................ 4288
Titration, amperometric (2.2.19.) ............................................. 41 Tri-n-butyl phosphate ............................................................ 4274
Titration, potentiometric (2.2.20.)............................................ 41 Tritiated (3H) water injection ................................................ 1332
Titration, voltametric (2.2.65.)................................................ 128 Trolamine................................................................................. 4289
Titrations, complexometric (2.5.11.)...................................... 182 Trometamol ............................................................................. 4291
Tizanidine hydrochloride ...................................................... 4233 Tropicamide............................................................................. 4292
TNF-alpha antagonists, cell-based assays for potency Tropisetron hydrochloride..................................................... 4293
dertermination of (2.7.26) .......................................... 11.1-4513 Trospium chloride .................................................................. 4295
Toadflax herb........................................................................... 1755 Troxerutin................................................................................ 4296
Tobramycin.............................................................................. 4235 Trypsin ..................................................................................... 4297
Tocopherol, all-rac-α-............................................................. 4236 Tryptophan .............................................................................. 4298
Tocopherol, RRR-α-................................................................ 4238

TSE, animal, minimising the risk of transmitting via human Vaccines for human use, conjugated polysaccharide, carrier
and veterinary medicinal products (5.2.8.) ......................... 698 proteins for the production of (5.2.11.) ............................... 711
TSE, animal, products with risk of transmitting agents of.. 942 Vaccines for human use, viral, tests for extraneous agents in
Tuberculin for human use, old.............................................. 4301 (2.6.16.) .................................................................................... 230
Tuberculin purified protein derivative, avian ..................... 4303 Vaccines for veterinary use...................................................... 955
Tuberculin purified protein derivative, bovine ................... 4303 Vaccines for veterinary use, inactivated, healthy chicken flocks
Tuberculin purified protein derivative for human use....... 4304 for the production of (5.2.13.) .............................................. 715
Tuberculosis (BCG) vaccine, freeze-dried........................... 1015 Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 185
Tubes for comparative tests (2.1.5.).......................................... 19 Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 185
Tubing and closures, silicone elastomer for (3.1.9.) ............. 462 Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 184
Tubing and containers for total parenteral nutrition Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 185
preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 460 Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 184
Tubing used in sets for the transfusion of blood and blood Vaccines, polysaccharide, protein in (2.5.16.)....................... 184
components, materials based on plasticised poly(vinyl Vaccines, polysaccharide, ribose in (2.5.31.)......................... 190
chloride) for (3.3.3.) ............................................................... 494 Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 186
Turkey infectious rhinotracheitis vaccine (live) ................. 1224 Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 186
Turmeric, Javanese.................................................................. 1760 Vaccines, SPF chicken flocks for the production and quality
Turmeric rhizome................................................................... 1761 control of (5.2.2.) ......................................................... 11.1-4539
Turpentine oil.......................................................................... 1762 Vaccines, substitution of in vivo method(s) by in vitro
Tylosin for veterinary use ...................................................... 4306 method(s) for the quality control of (5.2.14.) ..................... 716
Tylosin phosphate bulk solution for veterinary use ........... 4311 Vaccines, veterinary, cell cultures for the production of
Tylosin phosphate for veterinary use ................................... 4315 (5.2.4.) ...................................................................................... 686
Tylosin tartrate for veterinary use ........................................ 4320 Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 234
Typhae pollen.......................................................................... 1763 Vaginal and rectal dosage forms, solid, disintegration test for
Typhoid polysaccharide and hepatitis A (inactivated, (2.9.2.) ...................................................................................... 347
adsorbed) vaccine ................................................................. 1046 Vaginal capsules ............................................................. 11.1-4594
Typhoid polysaccharide vaccine ........................................... 1108 Vaginal delivery systems ............................................... 11.1-4594
Typhoid vaccine ...................................................................... 1110 Vaginal foams................................................................. 11.1-4594
Typhoid vaccine (live, oral, strain Ty 21a) .......................... 1110 Vaginal preparations ..................................................... 11.1-4593
Tyrosine ................................................................................... 4324 Vaginal preparations, semi-solid ................................. 11.1-4594
Tyrothricin............................................................................... 4326 Vaginal solutions, emulsions and suspensions........... 11.1-4594
Vaginal solutions or suspensions, powders and tablets
U for .................................................................................. 11.1-4594
Ubidecarenone ........................................................................ 4331 Vaginal tablets ................................................................ 11.1-4593
Udder-washes.......................................................................... 1009 Vaginal tampons, medicated ........................................ 11.1-4594
Ultraviolet and visible absorption spectrophotometry Valaciclovir hydrochloride .................................................... 4341
(2.2.25.) ...................................................................................... 48 Valaciclovir hydrochloride hydrate ...................................... 4344
Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 17 Valerian dry aqueous extract ............................................... 1766
Uncaria stem with hooks ....................................................... 1765 Valerian dry hydroalcoholic extract ..................................... 1767
Uncoated tablets ..................................................................... 1005 Valerian root............................................................................ 1768
Undecylenic acid..................................................................... 4332 Valerian root, cut .................................................................... 1770
Uniformity and accuracy of delivered doses from multidose Valerian tincture ..................................................................... 1771
containers (2.9.27.) ................................................................. 395 Valganciclovir hydrochloride ....................................... 11.1-4767
Uniformity of content of single-dose preparations (2.9.6.).. 358 Validation of nucleic acid amplification techniques for the
Uniformity of dosage units (2.9.40.)....................................... 421 detection of B19 virus (B19V) DNA in plasma pools :
Uniformity of dosage units, demonstration using large sample guidelines................................................................................. 236
sizes (2.9.47.) ........................................................................... 432 Validation of nucleic acid amplification techniques for the
Uniformity of mass of single-dose preparations detection of hepatitis C virus (HCV) RNA in plasma pools :
(2.9.5.) ........................................................................... 11.1-4523 guidelines................................................................................. 236
Units of the International System (SI) used in the Valine ....................................................................................... 4346
Pharmacopoeia and equivalence with other units (1.) .......... 3 Valnemulin hydrochloride for veterinary use .................... 4348
Unsaponifiable matter (2.5.7.)................................................. 181 Valproate, sodium................................................................... 4020
Urea .......................................................................................... 4333 Valproic acid............................................................................ 4349
Urofollitropin .......................................................................... 4333 Valsartan .................................................................................. 4351
Urokinase................................................................................. 4335 Vancomycin hydrochloride ................................................... 4352
Uronic acids in polysaccharide vaccines (2.5.22.) ................ 186 Vanillin..................................................................................... 4356
Ursodeoxycholic acid ............................................................ 4336 Vapour, preparations to be converted into............................ 994
Urtica dioica for homoeopathic preparations..................... 1849 Vardenafil hydrochloride trihydrate..................................... 4356
Varicella immunoglobulin for intravenous administration,
human .................................................................................... 3014
V
Varicella immunoglobulin, human ...................................... 3013
Vaccine component assay by immunonephelometry Varicella, measles, mumps and rubella vaccine (live)........ 1071
(2.7.35.) .................................................................................... 316 Varicella vaccine (live) ........................................................... 1112
Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 183 Vectors for human use, adeno-associated-virus ................... 824
Vaccines, adsorbed, calcium in (2.5.14.)................................ 184 Vectors for human use, adenovirus ........................................ 818
Vaccines and immunosera, phenol in (2.5.15.)..................... 184 Vectors for human use, plasmid ............................................. 816
Vaccines and immunosera, veterinary, evaluation of efficacy Vectors for human use, plasmid, bacterial cells used for the
of (5.2.7.).................................................................................. 697 manufacture of........................................................................ 817
Vaccines and immunosera, veterinary, evaluation of safety Vectors for human use, poxvirus ............................................ 820
(5.2.6.) ...................................................................................... 695 Vectors for human use, retroviridae-derived ........................ 822
Vaccines for human use ........................................................... 952 Vecuronium bromide ............................................................. 4357
Vaccines for human use, cell substrates for the production of Vedaprofen for veterinary use............................................... 4359
(5.2.3.) ...................................................................................... 682 Vegetable fatty oils .................................................................... 960
Venlafaxine hydrochloride .................................................... 4360 Water in gases (2.5.28.) ............................................................ 188

Verapamil hydrochloride ....................................................... 4361 Water : micro determination (2.5.32.) .................................... 190
Verbena herb ........................................................................... 1772 Water, purified ........................................................................ 4391
Veterinary liquid preparations for cutaneous application.. 1008 Water : semi-micro determination (2.5.12.) .......................... 183
Veterinary medicinal products, immunological, management Water-solid interactions : determination of sorption-
of extraneous agents in (5.2.5.) ............................................. 688 desorption isotherms and of water activity (2.9.39.) ......... 417
Veterinary semi-solid preparations for oral use ................. 1009 Wettability of porous solids including powders (2.9.45.) .... 429
Veterinary vaccines and immunosera, evaluation of efficacy of Wheat starch............................................................................ 4393
(5.2.7.) ...................................................................................... 697 Wheat-germ oil, refined......................................................... 4394
Viability, nucleated cell count and (2.7.29.) .......................... 312 Wheat-germ oil, virgin........................................................... 4394
Vibriosis (cold-water) vaccine (inactivated) for White beeswax ........................................................................ 2051
salmonids............................................................................... 1225 White horehound ................................................................... 1774
Vibriosis vaccine (inactivated) for salmonids ..................... 1226 White peony root.................................................................... 1663
Vibriosis vaccine (inactivated) for sea bass ......................... 1228 White soft paraffin.................................................................. 3637
VICH (5.8.)................................................................................ 791 Wild pansy (flowering aerial parts) ...................................... 1776
Vigabatrin ................................................................................ 4364 Wild thyme.............................................................................. 1777
Vinblastine sulfate .................................................................. 4365 Willow bark ............................................................................. 1778
Vincamine................................................................................ 4365 Willow bark dry extract ......................................................... 1779
Vincristine sulfate................................................................... 4367 Wool alcohols .......................................................................... 4395
Vindesine sulfate..................................................................... 4369 Wool fat.................................................................................... 4396
Vinorelbine tartrate ................................................................ 4370 Wool fat, hydrogenated.......................................................... 4399
Vinpocetine ............................................................................. 4372 Wool fat, hydrous.................................................................... 4401
Viper venom antiserum, European ...................................... 1238 Wormwood.............................................................................. 1780
Viral diarrhoea vaccine (inactivated), bovine ..................... 1138
Viral hepatitis type I vaccine (live), duck ................... 11.1-4604 X
Viral rhinotracheitis vaccine (inactivated), feline .............. 1176 Xanthan gum........................................................................... 4405
Viral rhinotracheitis vaccine (live), feline ........................... 1177 Xenon (133Xe) injection .......................................................... 1334
Viral safety (5.1.7.).................................................................... 667 X-ray fluorescence spectrometry (2.2.37.)............................... 71
Viral tenosynovitis vaccine (live), avian ..................... 11.1-4602 X-ray powder diffraction (XRPD), characterisation of
Viral vaccines for human use, tests for extraneous agents in crystalline and partially crystalline solids by (2.9.33.)....... 402
(2.6.16.) .................................................................................... 230 Xylazine hydrochloride for veterinary use .......................... 4406
Viscometer method, capillary (2.2.9.)...................................... 33 Xylitol ....................................................................................... 4407
Viscometer methods, falling ball and automatic rolling ball Xylometazoline hydrochloride.............................................. 4409
(2.2.49.) .................................................................................... 104 Xylose ....................................................................................... 4410
Viscose wadding, absorbent .................................................. 4373
Viscosity - rotating viscometer method (2.2.10.) ................... 33
Y
Viscosity (2.2.8.).......................................................................... 32
Visible and ultraviolet absorption spectrophotometry Yarrow ...................................................................................... 1781
(2.2.25.) ...................................................................................... 48 Yeasticidal, bactericidal or fungicidal activity of antiseptic
Visible particles, particulate contamination (2.9.20.) .......... 385 medicinal products, determination of (5.1.11.) .................. 673
Visible particles, recommendations on testing of particulate Yellow beeswax........................................................................ 2051
contamination (5.17.2.).......................................................... 839 Yellow fever vaccine (live) ..................................................... 1113
Vitamin A ................................................................................ 4375 Yellow soft paraffin................................................................. 3638
Vitamin A concentrate (oily form), synthetic ..................... 4376 Yersiniosis vaccine (inactivated) for salmonids .................. 1164
Vitamin A concentrate (powder form), synthetic .............. 4377 Yohimbine hydrochloride ............................................. 11.2-4971
Vitamin A concentrate (solubilisate/emulsion), Yttrium (90Y) chloride solution for radiolabelling.............. 1334
synthetic................................................................................. 4378
Voltametric titration (2.2.65.) ................................................. 128 Z
Volumetric analysis (4.2.) ........................................................ 638 Zanamivir hydrate .................................................................. 4419
Volumetric solutions (4.2.2.) ................................................... 639 Zanthoxylum bungeanum pericarp...................................... 1783
Volumetric solutions, primary standards for (4.2.1.)........... 638 Zidovudine .............................................................................. 4420
von Willebrand factor, human.............................................. 3014 Zinc acetate dihydrate ............................................................ 4422
von Willebrand factor, human, assay of (2.7.21.) ................. 305 Zinc acexamate ....................................................................... 4423
Voriconazole............................................................................ 4380 Zinc chloride ........................................................................... 4424
Zinc gluconate......................................................................... 4425
W Zinc oxide ................................................................................ 4426
Warfarin sodium..................................................................... 4385 Zinc stearate ............................................................................ 4426
Warfarin sodium clathrate..................................................... 4386 Zinc sulfate heptahydrate ...................................................... 4427
Washes, ear ................................................................................ 970 Zinc sulfate hexahydrate ........................................................ 4427
Washes, nasal............................................................................. 984 Zinc sulfate monohydrate...................................................... 4427
Water (15O) injection .............................................................. 1333 Zinc undecylenate .................................................................. 4428
Water activity and sorption-desorption isotherms, Ziprasidone hydrochloride monohydrate............................ 4428
determination of (water-solid interactions) (2.9.39.)......... 417 Ziprasidone mesilate trihydrate ............................................ 4431
Water, determination by distillation (2.2.13.) ......................... 37 Zoledronic acid monohydrate............................................... 4433
Water for diluting concentrated haemodialysis solutions.. 2935 Zolmitriptan ............................................................................ 4434
Water for injections ....................................................... 11.1-4773 Zolpidem tartrate.................................................................... 4436
Water for pharmaceutical use, total organic carbon in Zopiclone ................................................................................. 4438
(2.2.44.) ...................................................................................... 85 Zoster (shingles) vaccine (live), herpes................................ 1100
Water for preparation of extracts.......................................... 4390 Zuclopenthixol decanoate...................................................... 4439
Water in essential oils (2.8.5.) ................................................. 322

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EUROPEAN PHARMACOPOEIA 11.

English index ..................................................................... 4975 Latin index .............................................................................. 5011

1. General notices......................................................................... 3 2.2.65. Voltametric titration .................................................... 128

2.5.27. Oxygen in gases............................................................ 188 2.6.8. Pyrogens.......................................................................... 215

4976 See the information section on general monographs (cover pages)

5.18. Methods of pretreatment for preparing traditional Aceclofenac.............................................................................. 1861

4978 See the information section on general monographs (cover pages)

Allergen products, pollens for............................................... 3743 Ampicillin ................................................................................ 1963

4980 See the information section on general monographs (cover pages)

Benzethonium chloride ......................................................... 2063 Blackcurrant leaf ..................................................................... 1430

Butyl parahydroxybenzoate................................................... 2144 Capillary viscometer method (2.2.9.)....................................... 33

4982 See the information section on general monographs (cover pages)

Cefazolin sodium.................................................................... 2234 Chinese motherwort .............................................................. 1459

4984 See the information section on general monographs (cover pages)

Desﬂurane................................................................................ 2483 Dihydrotachysterol ................................................................. 2549

4986 See the information section on general monographs (cover pages)

Equine inﬂuenza vaccine (inactivated) ................................ 1167 Etofenamate............................................................................. 2727

4988 See the information section on general monographs (cover pages)

Fat, hard ................................................................................... 2949 Flucloxacillin sodium monohydrate..................................... 2781

Framycetin sulfate .................................................................. 2851 General notices (1.) ...................................................................... 3

4990 See the information section on general monographs (cover pages)

Guar.......................................................................................... 1545 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine

Houttuynia herb...................................................................... 1560 Hydrocortisone hydrogen succinate..................................... 3027

4992 See the information section on general monographs (cover pages)

Ion-selective electrodes, potentiometric determination of Lacosamide.............................................................................. 3185

4994 See the information section on general monographs (cover pages)

Liquid glucose, spray-dried ................................................... 2898 Macrogolglycerol hydroxystearate........................................ 3288

4996 See the information section on general monographs (cover pages)

Neostigmine bromide............................................................. 3491 Normal immunoglobulin for intramuscular administration,

4998 See the information section on general monographs (cover pages)

Opium tincture, standardised ............................................... 1650 Paraben, propyl ....................................................................... 3821

Pentazocine hydrochloride.................................................... 3658 Phenothiazines, identiﬁcation by thin-layer chromatography

5000 See the information section on general monographs (cover pages)

5002 See the information section on general monographs (cover pages)

Quality of non-sterile pharmaceutical preparations and Red peony root........................................................................ 1662

5004 See the information section on general monographs (cover pages)

Sodium cyclamate................................................................... 3986 Solids, density of (2.2.42.).......................................................... 82

Sprays, oromucosal................................................................... 986 Sublingual sprays ...................................................................... 986

5006 See the information section on general monographs (cover pages)

Swine-fever vaccine (live, prepared in cell cultures), Telmisartan.............................................................................. 4146

5008 See the information section on general monographs (cover pages)

Venlafaxine hydrochloride .................................................... 4360 Water in gases (2.5.28.) ............................................................ 188

5010 See the information section on general monographs (cover pages)

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