1-Methyl-1-phenylhydrazine / NMA Starting material

α-Methylphenylhydrazine (N-Methyl-N-phenylhydrazine / 1-Methyl-1-phenylhydrazine) is an aromatic hydrazine derivative widely used as a starting material and key synthetic intermediate in pharmaceutical and fine-chemical manufacturing. This compound, commonly referred to as NMA, has the molecular formula C7H10N2, a molecular weight of 122.17 g/mol, and is typically associated with CAS No. 618-40-6. NMA plays a valuable role in the construction of heterocyclic supports, reductive transformations, and other specialized organic reactions. Although NMA itself is not a nitrosamine, hydrazine-based structures can undergo nitrosation when exposed to nitrite sources or acidic nitrosating conditions, making it relevant within nitrosamine risk-assessment bases set forth by the U.S. FDA, EMA, and ICH M7. These guidelines require manufacturers to evaluate and control the potential formation of nitrosated derivatives when hydrazine precursors are used in API synthesis.

At Manasa Life Sciences, we provide end-to-end support for managing nitrosamine risks associated with hydrazine-containing starting materials such as NMA. Our services include comprehensive nitrosation-risk evaluation, assessment of manufacturing pathways, review of nitrite and reagent controls, and development/validation of high-sensitivity analytical methods (LC-MS/MS, GC-MS) for detecting possible nitrosated species at trace levels. Through robust quality systems and regulatory alignment, we help ensure safe, compliant, and reliable API development while minimizing nitrosamine-related risks throughout the manufacturing lifecycle.