Vildagliptin N-Hydroxy é uma impureza oxidativa relevante no perfil de impurezas de processos de fabricação de vildagliptina. Formada por N-oxidação durante etapas de síntese e armazenamento | esta impureza exige monitoramento rigoroso por HPLC e confirmação por LC-MS e RMN | incluindo massa exata e padrões de retenção. Sua presença pode afetar estabilidade | pureza e requisitos de qualificação toxicológica | e portanto deve ser controlada por otimização de condições reacionais | uso de atmosfera inerte | antioxidantes e etapas de purificação cromatográfica. Especificações | limites e métodos analíticos validados são essenciais para conformidade regulatória.
Referências
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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