A impureza Vildagliptin Dimer Impurity (CAS 1036959-23-5) | também conhecida como Vildagliptin Tertiary-Amine Impurity (free base) | é um subproduto de acoplamento que pode surgir durante a síntese e armazenamento do API Vildagliptina. Quimicamente trata-se de um dímero amínico terciário com propriedades fisicoquímicas distintas do monômero | afetando solubilidade e perfil cromatográfico. A identificação e quantificação por HPLC | LC-MS e espectroscopia NMR são essenciais para controle de processo e avaliação de estabilidade. A presença desta impureza requer investigação de origem e limiares aceitáveis conforme boas práticas regulatórias para garantir segurança e qualidade do lote farmacêutico.
Referências
By Chantal Mathieu Container: Vascular Health and Risk Management Year: 2008 Volume: Volume 4 DOI: 10.2147/vhrm.s3005 URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2663430/
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