Vildagliptin-(2R)-Isomer, CAS 1036959-27-9, ist eine stereochemische Verunreinigung des Dipeptidylpeptidase-4-Inhibitors Vildagliptin und entsteht typischerweise durch Epimerenbildung oder unvollständige Stereokontrolle während der Synthese. Mit der Summenformel C17H25N3O2 und einer molaren Masse von 303,4 g/mol handelt es sich nicht um ein Strukturanalogon, sondern um ein Konfigurationsisomer mit potenziell veränderten Bindungseigenschaften und chromatographischem Verhalten. Die Bestimmung erfordert üblicherweise chirale LC mit UV- oder MS-Detektion sowie Bestätigung durch LC-MS/MS, NMR oder hochauflösende Massenspektrometrie. Regulatorisch wird es als prozessbedingte Verunreinigung im Rahmen der pharmazeutischen Impuritätskontrolle bewertet.
References
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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