Impureza P de bicalutamida (CAS 937802-59-0) es un subproducto estructuralmente relacionado que aparece durante síntesis y almacenamiento. Su identificación y cuantificación son críticas para el control de calidad y cumplimiento regulatorio. Características analíticas incluyen retención específica en HPLC | señales detectables por LC-MS y confirmación estructural por RMN. La presencia de Impureza P puede afectar pureza | estabilidad y perfil de degradación del lote; por ello se investigan rutas sintéticas | condiciones de reacción y parámetros de purificación para minimizar su formación. Se recomiendan límites especificados | métodos analíticos validados y estudios de estrés para asegurar cumplimiento de especificaciones farmacéuticas.
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