Impureza Vildagliptin Imine (CAS 1789703-37-2) | também referida como Vildagliptin Cyclo Imidamide | Vildagliptin Impurity A ou Vildagliptin Mono Keto Impurity | é um subproduto de síntese caracterizado pela presença de um grupo imina conjugado ao núcleo hexahidropirrolo[1 | 2-a]pirazina. Esta impureza apresenta propriedades físico-químicas distintas que afetam o perfil de pureza e a estabilidade do API | sendo detectável por cromatografia líquida de alta eficiência com espectrometria de massas e por RMN para confirmação estrutural. Controle de formação | limites analíticos e estratégias de remoção durante etapas de purificação são essenciais para atendimento a especificações regulatórias e garantia de qualidade do lote.
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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