Diflorasone Diacetate Ointment

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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» Diflorasone Diacetate Ointment contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₂₆H₃₂F₂O₇ 

1 Packaging and storage

- Preserve in collapsible tubes, preferably at controlled roo m temperature.

2 USP REFERENCE STANDARDS (11)-

USP Diflorasone Diacetate RS

3 Identification

- It responds to the Identification test under Diflorasone Diacetate Cream.

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.

4 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(R_U/R_S)

in which the terms are as defined therein.