Benzamide, 4-[3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methyl-;
4-{3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide [915087-33-1]
BRIEFING
Enzalutamide. 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 ZORBAX StableBond-CN of column with L10 packing. The typical retention time for enzalutamide is about 24 min.
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The liquid chromatographic procedure in the test for Limit of Enzalutamide Related Compound G and Enzalutamide Related Compound H was validated using the Sunfire C18 brand of column with L1 packing. The typical retention times for enzalutamide related compound G and enzalutamide related compound H are about 21 and 22 min, respectively.
Manufacturers are encouraged to share any information pertaining to the mutagenicity of enzalutamide related compound G and enzalutamide related compound H with USP.
Description and solubility information: White to off-white solid. Freely soluble in 1-methyl-2-pyrrolidone and in acetonitrile, soluble in methanol, sparingly soluble in absolute ethanol, and practically insoluble in aqueous solutions (pH 1–11).
(SM3: L. Lasker)
Case ID—SUB-1049; SUB-1932