N-Nitroso Vildagliptin L-Prolinamid, auch als Vildagliptin N-Nitroso-L-Prolinamid bezeichnet, ist eine nitrosaminbezogene Verunreinigung mit der CAS-Nummer 79108-51-3, der Summenformel C5H9N3O2 und einer molaren Masse von 143,1 g/mol. Als N-Nitroso-Derivat eines Prolinamid-Bausteins steht diese Verbindung in direktem Zusammenhang mit Nitrosierungsreaktionen, die bei der Synthese oder Lagerung aus der Exposition aminhaltiger Zwischenprodukte gegenüber nitrosierenden Agenzien entstehen können. Solche Spezies werden im Rahmen von ICH M7 wegen möglicher mutagener und genotoxischer Eigenschaften beurteilt. Die Bestimmung im Spurenbereich erfordert in der Regel LC-MS/MS, ergänzt durch hochauflösende LC-MS oder GC-MS nach geeigneter Derivatisierung, um sehr niedrige Nachweisgrenzen sicher zu erreichen.
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