Dimethyl amine/ NDMA starting material

N,N‑Dimethylamine (DMA) is a simple aliphatic amine, with molecular formula C₂H₇N and molecular weight  45.09 g/mol;CAS number 124‑40‑3. As a small, volatile amine, DMA is used in various chemical and industrial applications, but in the context of pharmaceuticals it is significant mainly as a potential precursor to nitrosamine impurities. Under acidic or nitrosating conditions for example, in presence of nitrites during API synthesis or formulation, DMA can react to form nitrosamines such as NDMA, which are known to carry carcinogenic risks. For instance, NDMA is assigned a strict acceptable intake limit of 96 ng/day under the latest U.S. Food and Drug Administration (FDA) “Recommended Acceptable Intake Limits for Nitrosamine Drug‑Substance‑Related Impurities (NDSRIs).” 

At Manasa Life Sciences, we emphasize nitrosamine‑control readiness by offering expert support in risk‑assessment, and validated ultra‑sensitive LC‑MS/MS and GC‑MS analytical methods to detect and quantify nitrosamine impurities deriving from precursors like DMA (or DMA‑containing solvents/intermediates). This helps ensure compliance with FDA/ICH guidance, supports manufacturing safety, and minimizes carcinogenic impurity exposure for patients.