N-Nitroso Desmethyl Escitalopram

N-Nitroso Desmethyl Escitalopram is a genotoxic and potentially carcinogenic nitrosamine impurity associated with Escitalopram, a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder, generalized anxiety disorder, and other mood disorders. The chemical structure of this impurity is (S)-N-(3-(5-Cyano-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amide, which forms via nitrosation of the secondary amine in N-desmethyl Escitalopram under conditions such as acidic, oxidative, or nitrite-contaminated environments during API synthesis, formulation, or degradation. CAS No: NA; Molecular Formula: C19H18FN3O2; Molecular Weight: 339.4g/mol. This impurity is non-volatile and highly potent, and according to the USFDA Carcinogenic Potency Categorization Approach (CPCA), it is classified as Potency Category 1, with acceptable intake limit of 26.5 ng/day, consistent with USFDA, EMA, and ICH M7 (R1) guidelines for genotoxic impurities.

At Manasa Life Sciences, we assist pharmaceutical manufacturers in managing N-Nitroso Desmethyl Escitalopram by performing comprehensive nitrosamine risk assessments, identifying synthetic and processing steps prone to nitrosation, controlling raw materials and excipients, and developing high-sensitivity analytical methods such as LC-MS/MS and GC-MS for reliable trace-level detection. These measures ensure GMP compliance, strong nitrosamine control strategies, and patient safety.