Allopurinol Nitroso Impurity 2

Allopurinol Nitroso Impurity 2 (chemical name: 9-Nitroso-9H-purin-6-ol) is a nitrosamine impurity structurally related to Allopurinol, a xanthine-oxidase inhibitor used to reduce uric acid levels and treat gout/hyperuricemia. The impurity has a molecular formula C5H3N5O2, a molecular weight of 165.11 g/mol, and CAS number NA. As with other nitrosamine drug-substance–related impurities (NDSRIs), N-Nitroso Allopurinol falls under global nitrosamine-control bases. Regulatory guidance from the U.S. Food and Drug Administration (FDA) establishes recommended acceptable intake limits for many nitrosamines based on carcinogenic-potency categorization. 

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.