N-Nitroso Desmethyl Clomipramine

N-Nitroso N-Desmethyl Clomipramine (N-[3-(2-chloro-5,6-dihydrobenzo[b][1]benzazepin-11-yl)propyl]-N-methylnitrous amide) is a genotoxic and potentially carcinogenic nitrosamine impurity. Cas.no: N/A ; Molecular formula: C18H20ClN3O  ; Molecular weight: 329.82 g/mol. It may form when the secondary amine group in N-desmethyl Clomipramine undergoes nitrosation, especially under acidic, oxidative, or nitrite-contaminated conditions during API synthesis, processing, or degradation.

Structurally, is classified under the USFDA Carcinogenic Potency Categorization Approach (CPCA). According to US FDA, EMA, and ICH M7 (R1) guidelines, it is considered Potency Category 1, with a default acceptable intake limit of 26.5 ng/day. Clomipramine itself is primarily used as a tricyclic antidepressant for the treatment of obsessive-compulsive disorder (OCD) and depression, available in oral tablet formulations.

At Manasa Life Sciences, we help pharmaceutical manufacturers manage N-Nitroso N-Desmethyl Clomipramine by performing nitrosamine risk assessments, identifying nitrosation-prone steps in synthesis and processing, and evaluating potential contributions from raw materials and excipients. High-sensitivity analytical methods such as LC-MS/MS and GC-MS are developed and validated for reliable trace-level detection. These measures enhance GMP compliance, strengthen nitrosamine control strategies, and ensure product quality and patient safety throughout drug development and commercial production.