Regorafenib EP Impurity C (CAS 1855006-12-0) es una impureza o subproducto detectado durante la síntesis de regorafenib que requiere monitorización rigurosa. Se caracteriza por un perfil analítico definido | incluyendo tiempo de retención específico en HPLC | iones observados en LC-MS y señales distintivas en espectroscopía RMN. Presenta propiedades fisicoquímicas relevantes para el control de calidad | como solubilidad limitada y comportamiento cristalino que puede afectar la purificación. Su presencia influye en la seguridad y eficacia del lote | por lo que se establecen límites específicos y se implementan estrategias de control como etapas de purificación | cromatografía preparativa y ensayos de identificación y cuantificación para asegurar conformidad con especificaciones farmacéuticas.
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