N-Nitroso-L-proline

Vildagliptin N-Nitroso-L-proline is a nitrosamine impurity formed when L-proline undergoes nitrosation, typically in the presence of nitrite under acidic or reactive conditions. As with other nitrosamines, it is classified as a potentially genotoxic and carcinogenic impurity, making its identification and control essential in pharmaceutical products. In Vildagliptin manufacturing, N-Nitroso-L-proline may appear as a process-related impurity or arise through nitrosation pathways involving synthesis intermediates, making it a key element in regulatory nitrosamine risk assessments. This impurity has a molecular formula of C5H8N2O3, a molecular weight of 144.13 g/mol, and is commonly referenced under CAS No. 7519-36-0. According to current USFDA nitrosamine guidelines, it falls under Potency Category 5 with an acceptable intake limit of 1500 ng/day. Evaluation and control must also align with applicable USP nitrosamine standards to ensure full pharmacopeial compliance.

At Manasa Life Sciences, we assist pharmaceutical manufacturers in detecting and managing this impurity through thorough risk assessment, analytical method development and validation, and strong impurity-control strategies. Our specialized capabilities support regulatory adherence, strengthen quality assurance, and enhance product safety throughout the drug development and manufacturing lifecycle.