N-Nitroso N-Desmethyl Terbinafine

N-Nitroso N-Desmethyl Terbinafine is a genotoxic and potentially carcinogenic nitrosamine impurity associated with terbinafine, an allylamine antifungal agent used for the treatment of onychomycosis and dermatophytic infections. Terbinafine is marketed in oral tablets and topical dosage forms such as creams, gels, and sprays; however, nitrosamine risk is primarily relevant to the oral API and solid oral dosage forms. Chemically, this impurity is described as (E)-N-(6,6-dimethylhept-2-en-4-yn-1-yl)-N-(naphthalen-1-ylmethyl)nitrous amide, arising from nitrosation of the secondary amine present in N-desmethyl terbinafine, a known metabolite and synthetic intermediate. CAS No: NA; Molecular Formula: C20H22N2O; Molecular Weight: 306.40 g/mol. The formation of N-Nitroso N-Desmethyl Terbinafine may occur during API synthesis, processing, or degradation, particularly when nitrite sources or nitrosating agents are present under acidic, oxidative, or elevated-temperature conditions that favor nitrosation reactions.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.