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Enzalutamide was recently approved for the treatment of castration-resistant prostate cancer. In this study, the related substances in enzalutamide bulk substance were analyzed qualitatively and quantitatively. Four degradation products (Oxi, A9, P1 and P2) of enzalutamide were isolated using semi-preparative liquid chromatography and characterized using nuclear magnetic resonance and mass spectrometry...
An improved and practical synthesis of enzalutamide was accomplished in five steps. Starting from 4-bromo-2-fluoro-benzonic acid, a methyl esterification, Ullmann ligation, methyl esterification, ring closing reaction and final methyl amidation provided the target in 35% total yield with 99.8% purity. Five identified impurities were also synthesized. This efficient and economical procedure avoids...
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