4-Nitroso-1-(4-fluorobenzoyl)piperazine

4-Nitroso-1-(4-fluorobenzoyl)piperazine, also described as ((4-fluorophenyl)(4-nitrosopiperazin-1-yl)methanone), is a genotoxic and potentially carcinogenic nitrosamine impurity that may form in pharmaceutical substances or intermediates containing piperazine amide structures. Chemically, this impurity represents nitrosation of the secondary piperazine nitrogen in a 4-fluorobenzoyl-substituted piperazine support. Formation can occur during API synthesis, processing, or degradation, particularly under acidic, oxidative, or nitrite-contaminated conditions and work-up steps involving nitrogen oxides. CAS No: 2892260-28-3 ; Molecular Formula:  C11H12FN3O2; Molecular Weight:  237.23 g/mol.

At Manasa Life Sciences, we support pharmaceutical manufacturers in the effective management of piperazine-derived nitrosamines, including 4-Nitroso-1-(4-fluorobenzoyl)piperazine, through comprehensive nitrosamine risk assessments, identification of nitrosation-prone synthetic and processing steps, and evaluation of potential contributions from raw materials, reagents, solvents, and excipients. We develop and validate high-sensitivity analytical methods, such as LC-MS/MS and GC-MS, for reliable trace-level detection and quantification. Our integrated scientific and regulatory approach strengthens nitrosamine-control strategies, ensures GMP and global regulatory compliance, and safeguards product quality and patient safety throughout drug development and commercial manufacturing.