Accessed from 36.71.237.
98 by belmont7 on Mon Nov 26 09:23:30 EST 2018
864 Chloramphenicol / Official Monographs
Labeling—Label it to indicate that it is for veterinary use
only.
Change to read:
USP Reference standards 〈11〉—
USP Chloramphenicol RS
•• (CN 1-May-2018)
. Sample solution: Nominally 0.1 mg/mL of chloram-
Identification—The retention time of the major peak in
the chromatogram of the Assay preparation corresponds to
that in the chromatogram of the Standard preparation as
obtained in the Assay.
Bacterial Endotoxins Test 〈85〉—It contains not more
than 0.2 USP Endotoxin Unit per mg of chloramphenicol.
Sterility Tests 〈71〉—It meets the requirements when
tested as directed for Membrane Filtration under Test for Ste-
rility of the Product to be Examined, 1 mL from each con-
tainer being transferred directly to the membrane filter.
pH 〈791〉: between 5.0 and 8.0, in a solution diluted with
water (1:1).
Other requirements—It meets the requirements under In-
jections and Implanted Drug Products 〈1〉.
Assay—
Mobile phase, Standard preparation, and Chromatographic
system—Prepare as directed in the Assay under Chloram-
phenicol.
Assay preparation—Transfer an accurately measured vol-
ume of Chloramphenicol Injection, equivalent to about
200 mg of chloramphenicol, to a 100-mL volumetric flask,
add Mobile phase to volume, and mix. Transfer 4.0 mL of
the resulting solution to a 100-mL volumetric flask, dilute
with Mobile phase to volume, and mix. Filter this solution
through a 0.5-µm or finer porosity filter.
Procedure—Proceed as directed for Procedure in the Assay
under Chloramphenicol. Calculate the quantity, in mg, of
USP Monographs
C11H12Cl2N2O5 in each mL of the Injection taken by the
formula:
2.5(C / V)(rU / rS)
in which V is the volume, in mL, of Injection taken, and the
other terms are as defined therein.
. Container Contents.
Chloramphenicol Ophthalmic Ointment
DEFINITION
Chloramphenicol Ophthalmic Ointment contains NLT
90.0% and NMT 130.0% of the labeled amount of chlor-
amphenicol (C11H12Cl2N2O5).
IDENTIFICATION
• A. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as
obtained in the Assay.
ASSAY
• PROCEDURE
Mobile phase: Methanol, glacial acetic acid, and water
(450:1:550)
Standard stock solution: 0.25 mg/mL of USP Chloram-
phenicol RS in methanol
Standard solution: 0.1 mg/mL of USP Chloramphenicol
RS from the Standard stock solution in Mobile phase.
Pass through a suitable filter, and use the clear filtrate.
Sample stock solution: Nominally 0.25 mg/mL of
chloramphenicol prepared as follows. Transfer a portion
of Ophthalmic Ointment containing nominally 25 mg
of chloramphenicol to a suitable conical flask. Add
20 mL of cyclohexane, mix, and sonicate for 2 min.
Official from August 1, 2018
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.
USP 41
Add 60 mL of methanol. Filter this mixture, collecting
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
50.0 mL of the resulting solution to a suitable round-
bottom flask, and evaporate to dryness by rotating the
flask under vacuum in a water bath at 35°. Dissolve the
residue in 50.0 mL of methanol.
phenicol from the Sample stock solution in Mobile phase.
Pass through a suitable filter, and use the clear filtrate.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 280 nm
Column: 4.6-mm × 10-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection volume: 10 µL
System suitability
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 1.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
chloramphenicol (C11H12Cl2N2O5) in the portion of
Ophthalmic Ointment taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
rU = peak height from the Sample solution
rS = peak height from the Standard solution
CS = concentration of USP Chloramphenicol RS in
the Standard solution (mg/mL)
CU = nominal concentration of chloramphenicol in
the Sample solution (mg/mL)
P = potency of chloramphenicol in USP
Chloramphenicol RS (µg/mg)
F = conversion factor, 0.001 mg/µg
Acceptance criteria: 90.0%–130.0%
SPECIFIC TESTS
• STERILITY TESTS 〈71〉: Meets the requirements
• 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
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in collapsible
ophthalmic ointment tubes.
• USP REFERENCE STANDARDS 〈11〉
USP Chloramphenicol RS
Chloramphenicol Ophthalmic Solution
.
» Chloramphenicol Ophthalmic Solution is a ster-
ile solution of Chloramphenicol. It contains not
less than 90.0 percent and not more than
130.0 percent of the labeled amount of
C11H12Cl2N2O5.
Packaging and storage—Preserve in tight containers, and
store in a refrigerator until dispensed. The containers or in-
dividual cartons are sealed and tamper-proof so that sterility
is assured at time of first use.
Labeling—The labeling states that there is a 21-day be-
yond-use period after dispensing.