Chloramphenicol Cream
» Chloramphenicol Cream 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 tubes or in tight containers.
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.
Minimum fill 755:
meets the requirements.
Assay
Standard preparation
Transfer about 40 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 50-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 Chloramphenicol Cream, equivalent to about 40 mg of chloramphenicol, to a 100-mL volumetric flask, add about 80 mL of methanol, and sonicate for about 10 minutes. Cool to room temperature, dilute with methanol to volume, and mix. Transfer 10.0 mL of the resulting solution to a 50-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 the portion of Cream taken by the formula:
0.5C(rU / rS)
in which the terms are as defined therein.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1886
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
|