Chloramphenicol Ophthalmic Ointment

Accessed from 36.71.237.
98 by belmont7 on Mon Nov 26 09:23:30 EST 2018
864 Chloramphenicol / Official Monographs USP 41
Labeling—Label it to indicate that it is for veterinary use Add 60 mL of methanol. Filter this mixture, collecting
only. the filtrate in a 100-mL volumetric flask. Wash the filter
with methanol, collecting the washings in the volumet-
ric flask. Dilute with methanol to volume. Transfer
Change to read: 50.0 mL of the resulting solution to a suitable round-
bottom flask, and evaporate to dryness by rotating the
USP Reference standards 〈11〉— flask under vacuum in a water bath at 35°. Dissolve the
USP Chloramphenicol RS residue in 50.0 mL of methanol.
•• (CN 1-May-2018)
. Sample solution: Nominally 0.1 mg/mL of chloram-
Identification—The retention time of the major peak in phenicol from the Sample stock solution in Mobile phase.
the chromatogram of the Assay preparation corresponds to Pass through a suitable filter, and use the clear filtrate.
that in the chromatogram of the Standard preparation as Chromatographic system
obtained in the Assay. (See Chromatography 〈621〉, System Suitability.)
Bacterial Endotoxins Test 〈85〉—It contains not more Mode: LC
than 0.2 USP Endotoxin Unit per mg of chloramphenicol. Detector: UV 280 nm
Column: 4.6-mm × 10-cm; 5-µm packing L1
Sterility Tests 〈71〉—It meets the requirements when Flow rate: 1 mL/min
tested as directed for Membrane Filtration under Test for Ste- Injection volume: 10 µL
rility of the Product to be Examined, 1 mL from each con- System suitability
tainer being transferred directly to the membrane filter. Sample: Standard solution
pH 〈791〉: between 5.0 and 8.0, in a solution diluted with Suitability requirements
water (1:1). Tailing factor: NMT 2.0
Other requirements—It meets the requirements under In- Relative standard deviation: NMT 1.0%
jections and Implanted Drug Products 〈1〉. Analysis
Assay— Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
Mobile phase, Standard preparation, and Chromatographic chloramphenicol (C11H12Cl2N2O5) in the portion of
system—Prepare as directed in the Assay under Chloram- Ophthalmic Ointment taken:
phenicol.
Assay preparation—Transfer an accurately measured vol- Result = (rU/rS) × (CS/CU) × P × F × 100
ume of Chloramphenicol Injection, equivalent to about
200 mg of chloramphenicol, to a 100-mL volumetric flask, rU = peak height from the Sample solution
add Mobile phase to volume, and mix. Transfer 4.0 mL of rS = peak height from the Standard solution
the resulting solution to a 100-mL volumetric flask, dilute CS = concentration of USP Chloramphenicol RS in
with Mobile phase to volume, and mix. Filter this solution the Standard solution (mg/mL)
through a 0.5-µm or finer porosity filter. CU = nominal concentration of chloramphenicol in
Procedure—Proceed as directed for Procedure in the Assay the Sample solution (mg/mL)
under Chloramphenicol. Calculate the quantity, in mg, of P = potency of chloramphenicol in USP
USP Monographs
C11H12Cl2N2O5 in each mL of the Injection taken by the Chloramphenicol RS (µg/mg)

formula: F = conversion factor, 0.001 mg/µg
Acceptance criteria: 90.0%–130.0%
2.5(C / V)(rU / rS)
SPECIFIC TESTS
in which V is the volume, in mL, of Injection taken, and the • STERILITY TESTS 〈71〉: Meets the requirements
other terms are as defined therein. • OTHER REQUIREMENTS: It meets the requirements for Par-
ticulate and Foreign Matter and Container Contents in
Ophthalmic Products—Quality Tests 〈771〉, Drug Product
Quality, Universal Tests, Particulate and Foreign Matter and
. Container Contents.
Chloramphenicol Ophthalmic Ointment ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in collapsible
DEFINITION ophthalmic ointment tubes.
Chloramphenicol Ophthalmic Ointment contains NLT • USP REFERENCE STANDARDS 〈11〉
90.0% and NMT 130.0% of the labeled amount of chlor- USP Chloramphenicol RS
amphenicol (C11H12Cl2N2O5).
IDENTIFICATION
• A. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as
Chloramphenicol Ophthalmic Solution
.
obtained in the Assay.

ASSAY
• PROCEDURE » Chloramphenicol Ophthalmic Solution is a ster-
Mobile phase: Methanol, glacial acetic acid, and water ile solution of Chloramphenicol. It contains not
(450:1:550) less than 90.0 percent and not more than
Standard stock solution: 0.25 mg/mL of USP Chloram- 130.0 percent of the labeled amount of
phenicol RS in methanol
Standard solution: 0.1 mg/mL of USP Chloramphenicol C11H12Cl2N2O5.
RS from the Standard stock solution in Mobile phase. Packaging and storage—Preserve in tight containers, and
Pass through a suitable filter, and use the clear filtrate. store in a refrigerator until dispensed. The containers or in-
Sample stock solution: Nominally 0.25 mg/mL of dividual cartons are sealed and tamper-proof so that sterility
chloramphenicol prepared as follows. Transfer a portion is assured at time of first use.
of Ophthalmic Ointment containing nominally 25 mg
of chloramphenicol to a suitable conical flask. Add Labeling—The labeling states that there is a 21-day be-
20 mL of cyclohexane, mix, and sonicate for 2 min. yond-use period after dispensing.
Official from August 1, 2018

Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.

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Accessed from 36.71.237.

98 by belmont7 on Mon Nov 26 09:23:30 EST 2018

864 Chloramphenicol / Official Monographs USP 41

C11H12Cl2N2O5 in each mL of the Injection taken by the Chloramphenicol RS (µg/mg)

obtained in the Assay.

Official from August 1, 2018

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