Vildagliptin Imine Impurity (CAS 1789703-37-2) | también conocida como Vildagliptin Cyclo Imidamide | Vildagliptin Impurity A o Vildagliptin Mono Keto Impurity | es una impureza estructural relevante en el perfil de procesos de síntesis y estabilidad de Vildagliptin. Se caracteriza por una ciclización imínica parcial o alteración carbonílica que puede generarse durante síntesis | purificación o almacenamiento | y requiere identificación y cuantificación por HPLC | LC-MS y RMN para el control de calidad. Su presencia impacta la impureza total del API y exige límites | estándares de referencia y estrategias de mitigación conforme a guías regulatorias ICH para garantizar la calidad del producto final.
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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