Nilotinib Impurity 18 (CAS 2469039-94-7) es una impureza relacionada con nilotinib identificada durante el desarrollo y la producción | cuya caracterización analítica es crucial para el control de calidad. Su detección y cuantificación se realiza mediante HPLC-UV y LC-MS | confirmando masa molecular y fragmentación con HRMS y estructura con NMR 1D/2D. Presenta comportamiento en pruebas de degradación forzada que informa su vía de formación y estabilidad | y requiere límites especificados conforme a ICH Q3A/Q3B. Las estrategias de mitigación incluyen optimización de condiciones de síntesis | purificación dirigida y métodos analíticos validados para asegurar cumplimiento de especificaciones y seguridad farmacéutica.
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