Nilotinib N-óxido (CAS 1246817-85-5) es una impureza relacionada derivada de la N-oxidación de nilotinib que se genera durante procesos de síntesis y condiciones de estabilidad oxidativa. Su perfil analítico se caracteriza por LC-MS de alta resolución | cromatografía HPLC con detección UV y confirmación por RMN para determinar estructura y pureza. La identificación cuantitativa y el control siguen directrices ICH para niveles de impurezas | estableciendo límites de calificación y límites de detección adecuados. La presencia de Nilotinib N-óxido puede afectar perfiles de estabilidad y requiere estrategias de control en formulación y almacenamiento mediante antioxidantes | condiciones anóxicas y controles de proceso.
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