Vildagliptin IP Impurity B, auch als Vildagliptin-Amid-Impurität bezeichnet, CAS 565453-39-6, ist eine prozessbedingte Verunreinigung, die typischerweise durch Überacylierung oder Amidierung während der Vildagliptin-Herstellung entsteht. Mit der Summenformel C17H27N3O3 und einer Molekülmasse von 321.41 g/mol handelt es sich um ein strukturell definiertes Amidderivat und nicht um ein Nitrosamin oder einen einfachen hydrolytischen Abbauprodukt. Die Überwachung erfolgt im Rahmen der Anforderungen nach ICH Q3A und ICH Q3B; die Spurencharakterisierung erfordert üblicherweise RP-LC-MS/MS, hochauflösende LC-MS sowie bestätigende LC-UV-Verfahren. Festphasenisolierung und spektroskopische Zuordnung sichern die Abgrenzung vom Wirkstoff und anderen Synthesenebenprodukten.
References
Vildagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus By Louise Profit, Paul Chrisp, Carole Nadin Container: Core evidence Publisher: Dove Medical Press Year: 2008 Volume: 3 Issue: 1 DOI: 10.3355/ce.2008.009 URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2899806/
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