N-Methylethanamine / NMEA Starting material

N-Methylethanamine, also known as Ethylmethylamine, Methylaminoethane, Methylethylamine, N-Methyl-N-ethylamine, N-Methylethylamine, and N-Ethylmethylamine, is a secondary aliphatic amine commonly used as a starting material and intermediate in pharmaceutical and fine-chemical synthesis. It has the molecular formula C3H9N, a molecular weight of 59.11 g/mol, and is associated with CAS No. 624-78-2. Due to its secondary amine functionality, N-Methylethanamine can undergo nitrosation in the presence of nitrites under acidic or nitrosating conditions, potentially forming the nitrosamine impurity N-Nitroso-N-methylethanamine (NMEA nitrosamine).

Although N-Methylethanamine itself is not a nitrosamine, its ability to form a nitrosamine derivative makes it relevant under global nitrosamine-control bases, including USFDA, EMA, and ICH M7. The related nitrosamine impurity N-Nitroso-N-methylethanamine (NMEA-NO) is classified under the USFDA Carcinogenic Potency Categorization Approach (CPCA) as a Potency Category 1 nitrosamine, with a strict acceptable intake imit of 26.5 ng/day. Manufacturers using this starting material must, therefore, evaluate nitrosation risks, prevent nitrite introduction, and apply high-sensitivity analytical monitoring (LC-MS/MS, GC-MS). N-Methylethanamine is utilized in the manufacture of active pharmaceutical intermediates, specialty chemicals, agrochemicals, solvents, and amide derivatives. In the pharmaceutical sector, its key relevance is its role as a nitrosamine precursor, requiring careful control of process conditions, reagents, and storage environments to prevent nitrosamine formation.

At Manasa Life Sciences, we support manufacturers using N-Methylethanamine through comprehensive nitrosamine risk assessments, precursor pathway mapping, process optimization, and development of ultra-sensitive analytical methods designed to detect N-nitrosamine impurities at trace levels. Our solutions ensure full regulatory compliance, stronger impurity-control strategies, and improved quality and safety across all stages of API and drug-product manufacturing.