Bicalutamida EP Impurity A (CAS 90357-05-4) | también conocida como desfluoro bicalutamida o (+/-)-N-[4-cyano-3-(trifluorometil)fenil]-2-hidroxi-2-metil-3-(fenilsulfonil)propanamida | es una impureza relevante en el control del perfil de calidad del principio activo. Se caracteriza por pérdida del átomo de flúor respecto a la molécula parental y requiere identificación y cuantificación precisa mediante HPLC con detección UV | espectrometría de masas y resonancia magnética nuclear para confirmar su estructura y pureza. Su presencia puede afectar especificaciones | estabilidad y cumplimiento regulatorio | por lo que se implementan límites de especificación | métodos validados y estudios de eliminación en el proceso sintético.
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