Vildagliptin N-Hydroxy es una impureza relevante en el perfil de calidad del principio activo Vildagliptin | caracterizada por una modificación N-hidroxílica que puede formarse por oxidación durante síntesis o almacenamiento. Su identificación y cuantificación requieren métodos analíticos sensibles y específicos como HPLC con detección UV y LC-MS para confirmación estructural | además de técnicas NMR para caracterización. La presencia de Vildagliptin N-Hydroxy puede afectar la estabilidad y seguridad del lote | por lo que se recomienda establecer límites especificados | ensayos indicativos de estabilidad y controles de proceso que minimicen su formación. La trazabilidad mediante estándares de referencia facilita la conformidad regulatoria y la gestión del riesgo.
Referencias
By K.M. Prasanna Kumar, U. Phadke, H. Brath, A. Gawai, P.M. Paldánius, C. Mathieu Container: Primary Care Diabetes Year: 2016 Volume: 10 Issue: 6 DOI: 10.1016/j.pcd.2016.06.001 URL: https://www.sciencedirect.com/science/article/pii/S1751991816300432
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