N-(2,6-DIMETHYLPHENYL)-2-(4-NITROSOPIPERAZIN-1-YL)ACETAMIDE

N-(2,6-Dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide is a genotoxic and potentially carcinogenic nitrosamine impurity that may form during the synthesis, processing, or storage of piperazine-containing drug substances, particularly under acidic, oxidative, or nitrite-contaminated conditions that promote nitrosation of the secondary piperazine nitrogen. CAS No: 3038740-93-8; Molecular Formula:C14H20N4O2; Molecular Weight: 276.34 g/mol.  This impurity contains a 4-nitrosopiperazine moiety, which is highly susceptible to nitrosation, and is considered non-volatile and structurally alerting for genotoxicity.

At Manasa Life Sciences, we assist pharmaceutical manufacturers in managing N-(2,6-Dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide by conducting comprehensive nitrosamine risk assessments, identifying nitrosation-prone intermediates and synthetic steps, and evaluating potential contributions from raw materials and excipients. We develop and validate high-sensitivity analytical methods, including LC-MS/MS and GC-MS, for reliable trace-level detection. These measures support robust nitrosamine control strategies, ensure GMP compliance, and safeguard product quality and patient safety throughout drug development and commercial manufacturing.