Nilotinib Impurity 31 | CAS 915711-42-1 | es una impureza relacionada del proceso de síntesis de nilotinib que requiere identificación y control estrictos. Su caracterización se realiza mediante técnicas analíticas avanzadas | incluyendo HPLC para cuantificación | LC-MS para confirmación de masa y NMR para elucidación estructural. La presencia de esta impureza puede indicar rutas de degradación o pasos incompletos del proceso | por lo que se implementan límites de aceptación y estudios de estabilidad forzados para evaluar su formación. Estrategias de control incluyen optimización de condiciones de reacción | purificación y monitoreo en proceso | garantizando cumplimiento con especificaciones y seguridad del lote.
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