Bicalutamide EP Impurity B (CAS 1159977-36-2) es una impureza relacionada estructuralmente con la bicalutamida | descrita por sus sinónimos 2-fluoro-4-desfluoro bicalutamide y N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(2-fluorophenylsulfonyl)-2-hydroxy-2-methylpropanamide; presenta un núcleo aromático 2-fluorado y un grupo sulfonilo que modifican su polaridad y comportamiento cromatográfico. Su identificación y cuantificación requieren técnicas analíticas avanzadas como HPLC | LC-MS y RMN para confirmar la estructura y evaluar perfil de impurezas. El control mediante estándares de referencia | límites especificados y estudios de estabilidad es esencial para la gestión de calidad y cumplimiento regulatorio durante desarrollo y producción.
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