N-(4-Chlorobenzyl)-N-(pyridin-2-yl)nitrosoamine

N-Nitroso-p-Chloro-Benzylamino-Pyridine (N-CBAP) is a genotoxic and potentially carcinogenic nitrosamine impurity that may form in drug substances or intermediates containing benzylamine–pyridine secondary amine motifs. Chemically, it is described as N-(4-chlorobenzyl)-N-(pyridin-2-yl)nitrosoamine, indicating nitrosation of a secondary amine linking a chlorobenzyl group and a pyridinyl moiety. CAS.No: NA; Molecular formula: C12H10ClN3O; Molecular weight: 247.68. Formation of N-CBAP can occur during API synthesis, processing, or degradation, particularly in the presence of nitrite impurities, acidic conditions, oxidative environments, or exposure to nitrogen oxides during quenching, work-up, or storage.

At Manasa Life Sciences, we support pharmaceutical manufacturers in the effective management of N-CBAP by conducting comprehensive nitrosamine risk assessments, identifying nitrosation-prone synthetic routes and intermediates, and evaluating potential contributions from raw materials, reagents, solvents, and excipients. We develop and validate high-sensitivity analytical methods, including LC-MS/MS and GC-MS, for reliable trace-level detection and quantification. Our integrated approach strengthens nitrosamine-control strategies, ensures GMP and global regulatory compliance, and safeguards product quality and patient safety throughout drug development and commercial manufacturing.