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Difluprednate
C27H34F2O7 508.56
 Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)-, (6α,11β)-;
 6α,9-Difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate;
 (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-3,20-dioxypregna-1,4-dien-17-yl butyrate [23674-86-4]

BRIEFING

 Difluprednate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.

  1. The liquid chromatographic procedure in the Assay was validated using the LiChrospher 100 RP-18 brand of column with L1 packing. The typical retention time for difluprednate is about 6 min.

  2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the ACE C18 brand of column with L1 packing. The typical retention time for difluprednate is about 25 min.

Description and solubility information: A white to creamy-white crystalline powder. Freely soluble in acetonitrile and chloroform; soluble in dioxane; sparingly soluble in methanol and ethanol (96%); practically insoluble in water and ether.

 (SM5: R. Radhakrishnan)

 Case ID—SUB-628

USP REFERENCE STANDARDS FOR PURCHASE

USP Difluprednate RS
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