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.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.