2-Nitrosopyridine

2-Nitrosopyridine (also known as Nitroso Pyridine Impurity or Pyridine, 2-nitroso) is a nitrosated aromatic heterocycle with the molecular formula C₅H₄N₂O, a molecular weight of 108.10 g/mol, and commonly associated with CAS No. 79917-37-6. This compound is not used as a raw material, but is instead considered a potential nitrosamine impurity that may form when pyridine derivatives or process intermediates containing pyridine rings are exposed to nitrosating agents, nitrite sources, or acidic reaction conditions. Due to its structure and toxicological relevance, 2-Nitrosopyridine falls under global nitrosamine-risk evaluation bases defined by regulatory authorities including the U.S. FDA, EMA, and ICH M7. Manufacturers using pyridine-based starting materials, solvents, or reagents must assess the possibility of 2-Nitrosopyridine formation and implement appropriate control strategies.

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.