Nilotinib Mono-N-óxido se presenta como una impureza oxidativa derivada de Nilotinib que requiere control riguroso en el desarrollo y la producción farmacéutica. Su perfil fisicoquímico incluye aumento de polaridad y masa molecular aproximadamente 16 u por incorporación de oxígeno en el nitrógeno | lo que altera la retención en HPLC y la respuesta en espectrometría de masas. La identificación y cuantificación mediante métodos validados como HPLC | MS y NMR permiten seguimiento durante síntesis | degradación y formulación. Establecer límites de aceptación | realizar estudios de estabilidad forzada y muestreo en proceso garantiza cumplimiento de especificaciones y seguridad del producto final.
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