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.

At Manasa Life Sciences, we support pharmaceutical manufacturers in identifying, evaluating, and controlling nitrosated species such as 2-Nitrosopyridine through comprehensive nitrosamine risk assessments, route-of-synthesis evaluation, and implementation of high-sensitivity analytical techniques (LC-MS/MS, GC-MS) capable of quantifying nitrosopyridine impurities at trace levels. Our expertise ensures full compliance with global regulatory expectations, strengthens impurity-control strategies, and contributes to the safety and reliability of API and drug-product manufacturing.