Vildagliptin Hydroxy Impurity es una impureza hidroxilada identificada durante el desarrollo y la estabilidad de vildagliptina. Técnica y analíticamente relevante | se caracteriza por su perfil cromatográfico y espectrométrico | y requiere monitorización por HPLC con detección UV y confirmación por espectrometría de masas. Su formación suele asociarse a reacciones de hidroxilación y degradación; por tanto su cuantificación y límites en especificaciones son críticos para el control de calidad y cumplimiento de ICH Q3A/Q3B. Ofrecemos información técnica sobre métodos validados de separación | criterios de aceptación y estrategias de mitigación para garantizar un perfil de impurezas robusto.
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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