Regorafenib Impurity 6 (CAS 1187945-05-6) es una impureza relacionada con el proceso de síntesis y degradación de regorafenib que exige control analítico estricto para garantizar la calidad del API. Su caracterización incluye perfil cromatográfico | determinación de masa por LC-MS y asignación estructural mediante RMN 1H/13C | además de estudios de degradación forzada para definir su vía de formación. Es fundamental establecer límites de aceptación y criterios de calificación conforme a ICH Q3A/Q3B | y aplicar estrategias de mitigación como optimización de etapas sintéticas y purificación preparativa. Métodos HPLC validados y monitoreo de estabilidad son clave para su detección precisa.
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