Diflorasone Diacetate Cream
» Diflorasone Diacetate Cream contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C26H32F2O7.
Packaging and storage
Preserve in collapsible tubes, preferably at controlled room temperature.
Identification
The chromatogram of the Assay preparation exhibits a major peak for diflorasone diacetate at a retention time that corresponds to that exhibited in the chromatogram of the Standard preparation obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62
It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755
meets the requirements.
Assay
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system
Proceed as directed in the Assay under Diflorasone Diacetate.
Assay preparation
Transfer an accurately weighed amount of Cream, equivalent to about 1 mg of diflorasone diacetate, to a suitable container. Add 30.0 mL of Internal standard solution, and shake for about 30 minutes. Centrifuge the solution, and remove and discard the top (excipient) layer. Use the lower, clear chloroform layer.
Procedure
Proceed as directed for Procedure in the Assay under Diflorasone Diacetate. Calculate the quantity, in mg, of diflorasone diacetate (C26H32F2O7) in the portion of Cream taken by the formula:
0.03C(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 2142
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
|