Vildagliptin N-Oxide es una impureza relacionada que se forma por oxidación del nitrógeno durante la síntesis o el almacenamiento del principio activo. Su presencia influye en el perfil de impurezas | la estabilidad y potencialmente en el perfil de seguridad del lote | por lo que requiere identificación y cuantificación precisas mediante HPLC con detección UV | LC-MS y resonancia magnética nuclear. El control se basa en optimización de procesos | uso de condiciones anóxicas o antioxidantes | límites en especificaciones y muestreo dirigido. Las estrategias analíticas se validan conforme a ICH Q3A y Q3B para asegurar cumplimiento de criterios de aceptación y trazabilidad durante desarrollo y liberación.
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