Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propyn-1-yl)-, (11β,17β)-;
11β-[p-(Dimethylamino)phenyl]-17β-hydroxy-17α-(1-propynyl)estra-4,9-dien-3-one;
11β-[4-(Dimethylamino)phenyl]-17β-hydroxy-17α-(prop-1-yn-1-yl)estra-4,9-dien-3-one [84371-65-3]
BRIEFING
Mifepristone. Because there is no existing USP monograph for this drug substance, a new pending monograph based on validated methods of analysis is proposed.
-
The isocratic liquid chromatographic procedures in the Assay and Organic Impurities test are based on analyses performed with the Suplex pKb 100 brand of column with L68 packing. The typical retention time for mifepristone is about 19.5 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph.
Description and Solubility information: Light-yellow to yellow powder. Freely soluble in methanol, in chloroform, and in acetone; poorly soluble in water, in hexane, and in isopropyl ether.
(SM5: R. Ravichandran; H. Ramanathan)
Case ID: SUB-440