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.
USP Reference standards 11
USP Diflorasone Diacetate RS
Microbial enumeration tests 61 and Tests for specified microorganisms 62 Proceed with Ointment as directed for Microbial limits under Diflorasone Diacetate Cream.
Minimum fill 755: meets the requirements.
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.
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USP35NF30 Page 2898