9-Nitroso-9H-purin-6-ol

N-Nitroso Allopurinol 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. 

At Manasa Life Sciences, we supply certified N-Nitroso Allopurinol reference standards with full characterization data. We support manufacturers by providing validated, ultra-sensitive LC-MS/MS and GC-MS analytical methods, enabling detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-derived, or degradation-derived. This helps pharmaceutical producers perform strong impurity risk assessments, maintain regulatory readiness, uphold global-standard quality control, and protect patient safety.