Regorafenib EP Impurity B (CAS 2141961-84-2) es una impureza relacionada estructuralmente presente en lotes intermedios y material de referencia de Regorafenib EP. Su perfil analítico muestra una masa molecular y fragmentación características detectables por LC-MS y un tiempo de retención reproducible en métodos HPLC validados. Se recomienda su identificación estructural completa y establecimiento de límites en especificaciones de producto por su potencial impacto en estabilidad y pureza. Las estrategias de control incluyen ensayos cuantitativos por HPLC | pruebas de degradación forzada y validación de métodos analíticos para asegurar trazabilidad | cumplimiento de especificaciones y control de calidad en el proceso de fabricación.
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