Pharmacopoeia

 Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’

means to make.
 It is a legal and official book issued by recognized authorities
usually appointed by Government of each country.
 It comprises list of pharmaceutical substances, formulae along with
their description and standards.

 List of Pharmacopeias:
a) Argentine b) Austrian c) Belgian d) Brazilian e) British
f) Chinese g) Egyptian h) European i) French j) German
k) Hungarian l) Indian m) International n) Italian o) Japanese
p) Yugoslavian q) Mexican r) Netherlands s) Nordic t) Polish
u) Portuguese v) Rumanian w) Russian x) Spanish y) Turkish
z) United state.
 Indian Pharmacopoeia
 First official Pharmacopeia of India appeared in 1868 which was
edited by Edward John Waring.
 In preindependence days, British Pharmacopeia was used in
India.
 The colonial addendum of BP 1898 was published in 1900
appeared as Government of India edition in 1901.
 In 1946 Government of India issued one list known as „The Indian
Pharmacopeial list‟
 Committee under chairmanship of Sir R. N. Chopra alongwith
other nine members prepared „The Indian Pharmacopeial list‟
 It was prepared by Dept. of Health, Govt. of India, Delhi in 1946.
 In 1948 Government of India appointed an Indian Pharmacopeia
committee for preparing „Pharmacopeia of India‟
 Tenure of this committee was five years.
 Indian Pharmacopeia committee under chairmanship of Dr. B. N.
Ghosh Published first edition of IP in 1955.
 Indian Pharmacopoeia
 It is written in English & official titles of monographs given in
Latin.
 It covers 986 monographs.
 Supplement to this edition was published in 1960.
 Second edition of IP was published in 1966 under the
chairmanship of Dr. B. Mukkerji.
 Official titles of monographs given in English.
 Dose were expressed in Metric system.
 For Tablets and Injections “USUAL STRENGTH” have been given.
 Formulations of the drugs were given immediately after the
monograph of drugs.
 274 monographs from IP 55 & their supplement were deleted.
 93 new monographs were added.
 Supplement to this edition was published in 1975.
 126 new monographs have been included & 250 monographs
have been amended.
 Cholera vaccine has been deleted.
 Indian Pharmacopoeia
 Third edition of IP was published in 1985 with two volumes & nine
appendices.
 261 new monographs have been added.
 450 monographs were deleted.
 Addendum I to IP was published in 1989 were 46 new monographs
added and 126 amended.
 Addendum II was published in 1991 were 62 new monographs
added and 110 amended.
 Fourth edition of IP was published in 1996 under the chairmanship
of Dr. Nityanand.
 It has been made effective from 1st December 1996.
 It covered 1149 monographs and 123 appendices.
 It includes 294 new monographs & 110 monographs have been
deleted.
 Addendum I has been made effective from 31st December 2000
were 42 new monographs have been added.
 Addendum II has been made effective from 30th June 2003 were
19 new monographs have been added.
 The veterinary supplement to IP 1996 contains 208 monographs &
four appendices.
 Indian Pharmacopoeia

 Fifth edition of IP was published in 2007 & addendum to

this edition was published in 2008.

 IP 2007 is presented in Three Volumes.

 Volume One contains general notices & general

chapters.

 Volume Two & Three contains general monographs on

drug substances , dosage forms & Pharmaceutical aids.
 Indian Pharmacopoeia 2010
 6th editionof IP is published in 2010.
 The 6th edition of the Indian Pharmacopoeia 2010 is
published by the Indian Pharmacopoeia Commission (IPC)
Ghaziabad in accordance with a plan and completed through
the untiring efforts of its members, Secretariat and Laboratory
over a period of about two years.
 It supersedes the 2007 edition but any monograph of the
earlier edition that does not figure in this edition.
 This edition would be effective from 1st September, 2010.
 The Indian Pharmacopoeia 2010 is presented in three
volumes.
 Volume I contains the Notices, Preface, the Structure of the
IPC, Acknowledgements, Introduction, and the General
Chapters.
 Volume II contains the General Notice, General Monographs
on Dosage Forms and Monographs on drug substances,
dosage forms and pharmaceutical aids (A to M).
 Indian Pharmacopoeia 2010
 Volume III contains Monographs on drug substances,
dosage forms and pharmaceutical aids (N to Z).
 Followed by Monographs on Vaccines and Immunosera for
Human use, Herbs and Herbal products, Blood and blood-
related products, Biotechnology products and Veterinary
products.
 The scope of the Pharmacopoeia has been extended to
include products of biotechnology, indigenous herbs and
herbal products, veterinary vaccines and additional
antiretroviral drugs and formulations, inclusive of commonly
used fixed-dose combinations. Standards for new drugs and
drugs used under National Health Programmes are added
and the drugs as well as their formulations not in use now a
day are omitted from this edition.
 Indian Pharmacopoeia 2010
 The number of monographs of Excipients, Anticancer
drugs, Herbal products and antiretroviral drugs has been
increased in this edition.
 Monographs of Vaccines and Immunosera are also
upgraded in view of development of latest technology in
the field.
 A new chapter on Liposomal products and a monograph
of Liposomal Amphotericin B injection is an added
advantage in view of latest technology adopted for drug
delivery.
 A chapter on NMR is incorporated in Appendices.
 The chapter on microbial contamination is also updated
to a great extent to harmonise with prevailing
international requirements.
Seventh Edition of Indian Pharmacopoeia
 The seventh edition of the Indian Pharmacopoeia (IP 2014) is
published by the Indian Pharmacopoeia Commission (IPC)
on behalf of the Government of India, Ministry of Health &
Family Welfare.
 The Indian Pharmacopoeia 2014 is presented in four
volumes. The scope of the Pharmacopoeia has been extended
to include additional anticancer drugs & antiretroviral drugs
and formulations, products of biotechnology, indigenous
herbs and herbal products, veterinary vaccines.
 The IP 2014 incorporates 2550 monographs of drugs out of
which 577 are new monographs consisting of APIs,
excipients, dosage forms and herbal products etc.
Seventh Edition of Indian Pharmacopoeia

 A list of 577 New Monographs not included in IP-2010 and

its Addendum-2012 but added in this edition containing 313
New Monographs on drug substances, Dosage forms &
Pharmaceutical aids (A to Z), 43 New Drugs Substances
Monographs, 10 Antibiotic Monographs, 31 Herbal
Monographs, 05 Vaccines & immunosera for human use, 06
Insulin Products, 07 Biotechnology Products etc. along with
the 19 new General Chapters.
 19 New Radiopharmaceutical Monographs & 1 General
chapter is first time being included in this edition.
 This edition of Indian Pharmacopoeia-2014 is now under
printing and will be available to stakeholders probably in
Sept.2013, before three months of its effective date, i.e. 1st
Jan. 2014.
Indian Pharmacopoeia
 BRITISH Pharmacopoeia
 First edition of BP was published in 1864.
 It consist of two sections
 Part I:- Materia Medica & Part II:- Preparation & compounds.
 Second edition of BP was published in 1867.
 Fourth edition of BP was published in 1898.
 Fifth edition of BP was published in 1914.
 Eighth edition of BP was published in 1953.
 In this edition titles of drugs & preparations were in English
instead of Latin and metric system.
 It has been published annually.
 In BP 2007 monographs has been introduced for material
specifically used in preparation of Traditional Chinese medicines.
 Term „Prolonged release‟ has been replaced the term „Slow‟ and
the term „Gastro-resistant‟ has been replaced with „Enteric
coated‟ in number of monographs.
 BRITISH Pharmacopoeia

 BP 2008 contains approximately 3100 monographs for

substances, preparations and articles used in practice.
 It has been made effective from 1st January 2008.
 BP 2007 -2009 were given in Six Volumes i.e. Volume I to
Volume VI.
 Volume I & II contains medicinal substances.
 Volume III contains formulated preparations, blood related
products, immunological products, radiopharmaceutical
preparations, surgical materials & homoeopathic
preparations.
 Volume IV contains supplementary chapters, IR spectra etc.
 Volume V contains veterinary.
 Volume VI contains CD ROM version.
 Current edition of BP 2010 is in process.
 THE BRITISH PHARMACOPOEIA 2010
TSO (The Stationery Office), on behalf of the British
Pharmacopoeia Secretariat, part of the Medicines and Healthcare
products Regulatory Agency (MHRA), has recently published the
British Pharmacopoeia (BP) 2010.
The British Pharmacopoeia (BP) is the official collection of
standards for UK medicinal products and pharmaceutical substances.
Published annually, the BP contains monographs for pharmaceutical
substances, formulated preparations and other articles used in the
practice of medicine. The standards in the BP 2010 are legally
effective in the UK from 1 January 2010.
The BP has been providing authoritative, official standards for
pharmaceutical substances and medicinal products since 1864.
Today, it is used in almost 100 countries worldwide and remains an
essential reference for any individual or organisation working within
pharmaceutical research and development, manufacturing and
testing across the globe.
New to the BP 2010 are 40 monographs for formulated
preparations, including veterinary medicines and
additional standards for widely used unlicensed
formulations. All European Pharmacopoeia 6th edition
material up to and including Supplement 6.5 is
integrated into the text of the BP 2010. In addition to the
expanding number of monographs for licensed
formulated products, the BP supports the regulatory
work in the fields of herbal and complementary
medicines by providing additional new and revised
monographs for herbal medicinal products and for
homeopathic stocks and mother tinctures.
The print edition of the BP 2010 comprises four volumes
of the BP 2010 and a single volume of the BP
(Veterinary) 2010.
 THE BRITISH PHARMACOPOEIA (BP) 2013

The BP 2013 package includes:

Six volume printed edition including the BP (Veterinary) 2013
New for 2013:
41 new BP monographs
40 new European Pharmacopoeia monographs
619 amended monographs

6 new and 1 amended Infrared Reference Spectra

 THE BRITISH PHARMACOPOEIA 2014
The only official source of British pharmaceutical standards
Produced by the British Pharmacopoeia Commission Secretariat of the Medicines
and Healthcare Products Regulatory Agency, and updated annually, the British

Pharmacopoeia (BP) is the official, authoritative collection of standards for UK

medicinal substances for human and veterinary use.
The 2014 edition includes almost 3500 monographs which are legally enforced by
the Human Medicines Regulations 2012.

Global standards
Now used in over 100 countries, the BP remains an essential reference for all
individuals and organisations working within pharmaceutical research and

development, manufacture and testing around the globe.

Flexible access options
The BP 2014 package comprises five volumes of the British Pharmacopoeia
2014 and a single volume of the British Pharmacopoeia (Veterinary) 2014,
along with a fully searchable CD-ROM and online access to provide you with
flexible resources.

New for 2014

Legally effective from 1 January 2014
40 new BP monographs
272 amended monographs
Three new Supplementary Chapters
Four new BP (Vet) monographs

One new BP (Vet) Supplementary Chapter

BRITISH Pharmacopoeia
BRITISH Pharmacopoeia
 UNITED STATE Pharmacopoeia
 First edition of United state Pharmacopeia was published on 15th
December 1820 in both Latin & English.
 From 1820 to 1942 it was published at Ten years intervals.
 From 1942 to 2000 it was published at Five years intervals.
 From 2002 it was published annually.
 First National Formulary of the united state appeared in 1888.
 USP21-NF16 have eight supplements.
 First appeared in January 1985 & last in November 1988.
 USP22-NF17, 1990 is the third revision that consolidates USP &
NF into a single volume.
 Electronic version of USP-NF on floppy disks was introduced in
1992.
 USP23-NF18, was published in Mumbai as an Asian edition at the
end of 1994.
 UNITED STATE Pharmacopoeia
 USP23 has ten supplements.
 First supplement was published in January 1995 & Last in May 1999.
 USP24-NF19, appeared from first January 2000.
 USP30-NF25, appeared from May 2007.
 It contains Scientific standards for drugs, dietary substances, biological
products & Excipients used in dosage forms.
 It contains 4,100 monographs and 200 general chapters.
 It has been printed in three volume set.
 Volume I contains general chapters & Volume II & III contains
monographs.
 First supplement to USP30-NF25, appeared from August 2007 & second
supplement from November 2007 which will be considered official from
May 2008.
 From 2006, Spanish edition of USP is also being published.
 Current edition of USP 2014 is in process.
 UNITED STATES PHARMACOPOEIA 30 – NATIONAL
FORMULARY 25
Highlights include:
 New heavier paper stock
 Complete table of contents and index in each volume
 Special 'Using the New USP-NF Print' tutorial CD
 Convenient slipcase for easy access and storage (English edition
only).
 UNITED STATES PHARMACOPOEIA 31 - NATIONAL
FORMULARY 26
 The USP-NF is a single-volume combination of two official
compendia, the United States Pharmacopeia (USP) and the
National Formulary (NF). Monographs for drug substances and
preparations are featured in the USP, with monographs for
dietary supplements and ingredients appearing in a separate
section of the USP. Excipient monographs are included in the
NF.
 UNITED STATES PHARMACOPOEIA 32 - NATIONAL
FORMULARY 27
The USP 32-NF 27 Contains :
 More than 4,200 monographs
 Includes over 200 general chapters, covering general tests and
assays
 Displays helpful guides and charts that make it easy to find
focus-specific information
 Includes information on emerging areas of science and medicine
 Helps ensure compliance with official standards
 Enables validation of test results against proven benchmarks
 Creates in-house standards for operating procedures and
specifications
 Expedites new product development and approvals.
 UNITED STATES PHARMACOPOEIA 33 - NATIONAL
FORMULARY 28:
The USP 33-NF 28 Contains:
 More than 4,400 monographs
 Over 200 general chapters covering general tests and assays
 A new, easy-to-read format and monograph layout
 Helpful guides and charts that make it easy to find focus-specific
information
 Ensures compliance with official standards
 Establishes in-house standard operating procedures and
specifications
 Facilitates new product development and approval.
 UNITED STATES PHARMACOPEIA 34 - NATIONAL
FORMULARY 29:
USP 34-NF 29 features more than 4,500 monographs for drug
substances, dosage forms, excipients, biologics, dietary
supplements, and other therapeutics. USP 34-NF 29 also offers
harmonized material and more than 230 General Chapters with
current guidelines for the full range of laboratory tests and
established processes for validating methods.
 UNITED STATES PHARMACOPEIA 35 - NATIONAL
FORMULARY 30:
The 'United States Pharmacopeia 35 - National Formulary 30'
(USP-NF) is a combination of two official compendia: the
'United States Pharmacopeia (USP)' and the 'National Formulary
(NF)' and is officially applicable from 1 May, 2012 to 30 April,
2013.
UNITED STATE Pharmacopoeia
 European Pharmacopeia
 European pharmacopeia commission started working since
1964 to prepare EP
Editions
 1st edition: published 1967
 2nd edition: published 1980
 3rd edition: published 1997
 4th edition: published 2001, valid from 1 January 2002
 5th edition: published 15 June 2004, valid from 1 January
2005
 6th edition: published 16 July 2007, valid from 1 January
2008
 7th edition: published June 2010, valid from 1 January 2011
 8th edition: published June 2013, valid from 1 January 2014
Since its 5th edition, the pharmacopoeia is
published in 2 volumes. Volume 1 contains general
chapters and monographs (e.g. on dosage forms,
methods of analysis, reagents), volume 2 contains
all substance monographs. During runtime of
current edition several supplements are published.
Electronic versions are also available (CD-ROM,
USB stick and online version).
EUROPEAN PHARMACOPOEIA 8TH EDITION
PUBLISHED ON JUNE 2013
 The European Pharmacopoeia (Ph. Eur.) defines
requirements for the qualitative and quantitative
composition of medicines, the tests to be carried out on
medicines and on substances and materials used in their
production.
 It covers active substances, excipients and preparations of
chemical, animal, human or herbal origin, homoeopathic
preparations and homoeopathic stocks, antibiotics, as well
as dosage forms and containers. It also includes texts on
biologicals, blood and plasma derivatives, vaccines and
radiopharmaceutical preparations. The European
Pharmacopoeia and its requirements are legally binding in
the member states of the European Pharmacopoeia
Convention and the European Union.
European Pharmacopeia
European Pharmacopeia