N-Nitroso Vildagliptin L-Prolinamide, also described as Vildagliptin N-Nitroso-L-Prolinamide, is a nitrosamine-related impurity with CAS 79108-51-3, molecular formula C5H9N3O2, and molecular weight 143.1 g/mol. As an N-nitroso derivative of a prolinamide fragment, it is relevant to nitrosation chemistry arising from exposure of amine-containing intermediates to nitrosating agents during synthesis or storage. Such species are evaluated under ICH M7 because of potential mutagenic and genotoxic concern. Trace-level measurement generally requires LC-MS/MS, often complemented by high-resolution LC-MS or GC-MS after suitable derivatization, to resolve low-ng thresholds and confirm identity in complex pharmaceutical matrices.
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