Chloramphenicol Ophthalmic Ointment
» Chloramphenicol Ophthalmic Ointment 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 collapsible ophthalmic ointment tubes.
USP Reference standards 11
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: meets the requirements.
Minimum fill 755: meets the requirements.
Metal particles It meets the requirements under Metal Particles in Ophthalmic Ointments 751.
Standard preparation Transfer about 25 mg of USP Chloramphenicol RS, accurately weighed, to a 100-mL volumetric flask, dissolve in methanol, dilute with methanol to volume, and mix. Transfer 10.0 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 Standard preparation.
Assay preparation Transfer an accurately weighed quantity of Ophthalmic Ointment, equivalent to about 25 mg of chloramphenicol, to a suitable conical flask, add 20 mL of cyclohexane, mix, and sonicate for about 2 minutes. Add 60 mL of methanol, and mix. Filter this mixture, collecting the filtrate in a 100-mL volumetric flask. Wash the filter with methanol, collecting the washings in the volumetric flask. Dilute with methanol to volume, and mix. 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. Transfer 10.0 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.
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USP35NF30 Page 2608