5'H-Pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11β,16β);
11β,21-Dihydroxy-2'-methyl-5'βH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate [14484-47-0]
BRIEFING
Deflazacort. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedures in the Assay and the test for Organic Impurities were validated using the Hypersil-ODS brand of column with L1 packing. The typical retention time for deflazacort is about 14 min.
Manufacturers are encouraged to submit their FDA-approved Optical Rotation procedure, which does not require the use of a hazardous solvent.
Description and solubility information: White to off-white powder. Freely soluble in acetic acid and in dichloromethane; soluble in methanol and in acetone.
(SM5: R. Ivaturi)
Case ID—SUB-1948