Clopidogrel Nitroso Impurity

Clopidogrel Nitroso Impurity is a nitrosamine-related byproduct associated with Clopidogrel, a widely used antiplatelet medication indicated for reducing the risk of heart attack, stroke, and other cardiovascular events. Clopidogrel is available in common dosage forms such as film-coated tablets. Although the formation of Clopidogrel Nitroso Impurity is typically unintentional, it must be closely monitored due to the genotoxic potential of nitrosamines. Under current USFDA guidance, the predicted nitrosamine derivative related to Clopidogrel falls under Potency Category 5, with a recommended acceptable intake limit of 1500 ng/day. Additionally, impurity analysis and control must align with applicable USP standards to ensure pharmacopeial and regulatory 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.