U.S. PHARMACOPEIA

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Diflorasone Diacetate Ointment
» Diflorasone Diacetate Ointment 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— It responds to the Identification test under Diflorasone Diacetate Cream.
Microbial limits 61— Proceed with Ointment as directed for Microbial limits under Diflorasone Diacetate Cream.
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— Using Ointment instead of the Cream, proceed as directed for Assay preparation in the Assay under Diflorasone Diacetate Cream.
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 Ointment 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 697
Phone Number : 1-301-816-8143