Diflorasone Diacetate Cream, chemical structure, molecular formula, Reference Standards

Diflorasone Diacetate Cream

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

Packaging and storage— Preserve in collapsible tubes,preferably at controlled room temperature.

USP Reference standards á11ñ— USP Diflorasone Diacetate RS.

Identification— The chromatogram of the Assay preparationexhibits a major peak for diflorasone diacetate at a retention time that corresponds to that exhibited in the chromatogram of the Standard preparationobtained in the Assay.

Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.

Minimum fill á755ñ— meets the requirements.

Assay—

Mobile phase,Internal standard solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Diflorasone Diacetate.

Assay preparation— Transfer an accurately weighed amount of Cream,equivalent to about 1mg of diflorasone diacetate,to a suitable container.Add 30.0mLof Internal standard solution,and shake for about 30minutes.Centrifuge the solution,and remove and discard the top (excipient)layer.Use the lower,clear chloroform layer.

Procedure— Proceed as directed for Procedurein the Assayunder 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:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 638

Phone Number:1-301-816-8139