Lercanidipine Dimethyl Ester Nitroso Impurity

Lercanidipine Dimethyl Ester Nitroso Impurity is a predicted Nitrosamine Drug-Substance Related Impurity (NDSRI) associated with Lercanidipine, a calcium-channel blocker used for the treatment of hypertension and marketed in oral tablet dosage forms. This impurity may form during API synthesis, degradation, or exposure to nitrosating agents, especially under acidic or oxidative conditions. Its estimated chemical properties include a molecular formula C17H17N3O7, molecular weight 375.3g/mol, and CAS number: NA. This nitrosamine is not listed in the USFDA’s published acceptable-intake limits for nitrosamines and therefore has no assigned FDA potency category. Consequently, risk evaluation and control must follow general global nitrosamine guidance (USFDA Nitrosamine Guidance, ICH M7, EMA NDSRI approach), requiring manufacturers to identify possible formation pathways and verify presence or absence using sensitive analytical methods.

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.