N-Nitroso N-Desmethyl Doxylamine

N-Nitroso N-Desmethyl Doxylamine (N-methyl-N-(2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethyl)nitrous amide; (R)-N-methyl-N-(2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethyl)nitrous amide) is a genotoxic and potentially carcinogenic nitrosamine impurity. CAS No: NA; Molecular Formula: C16H19N3O2; Molecular Weight: 285.35g/mol. It can form when the secondary amine group in N-desmethyl Doxylamine undergoes nitrosation, particularly under acidic, oxidative, or nitrite-contaminated conditions during API synthesis, processing, or degradation.

As a structurally complex, it is classified under the USFDA Carcinogenic Potency Categorization Approach (CPCA). Following US FDA, EMA, and ICH M7 (R1) guidelines, it falls into Potency Category 1, with a default acceptable intake limit of 26.5 ng/day. Doxylamine itself is primarily used as an antihistamine for insomnia and allergy relief, available in oral tablet or syrup dosage forms.

At Manasa Life Sciences, we support pharmaceutical manufacturers in controlling N-Nitroso N-Desmethyl Doxylamine by conducting comprehensive nitrosamine risk assessments, identifying nitrosation-prone steps, and evaluating potential contributions from raw materials and excipients. We also develop and validate sensitive analytical methods, such as LC-MS/MS and GC-MS, for reliable trace-level detection and quantification. These efforts ensure GMP compliance, strengthen nitrosamine control strategies, and safeguard product quality and patient safety during drug development and commercial production.