U.S. PHARMACOPEIA

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Chloramphenicol Ophthalmic Solution
» Chloramphenicol Ophthalmic Solution is a sterile 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 individual 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 beyond-use period after dispensing.
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.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 7.0 and 7.5, except that in the case of Ophthalmic Solution that is unbuffered or is labeled for veterinary use it is between 3.0 and 6.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Chloramphenicol.
Standard preparation— Dissolve an accurately weighed quantity of USP Chloramphenicol RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 100 µg per mL. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Standard preparation.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 50 mg of chloramphenicol, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 5.0 mL of the resulting solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay under Chloramphenicol. Calculate the quantity, in mg, of C11H12Cl2N2O5 in each mL of the Ophthalmic Solution taken by the formula:
0.5(C / V)(rU / rS),
in which V is the volume, in mL, of Ophthalmic Solution taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 464
Phone Number : 1-301-816-8223