U.S. PHARMACOPEIA

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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 limits 61— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755— meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 696
Phone Number : 1-301-816-8143