Diethyl amine/ NDEA starting material

N,N‑Diethylamine (DEA / N‑Ethylethanamine) is a small secondary aliphatic amine with molecular formula C4H11N molecular weight 73.14 g/mol, and CAS number 109-89-7. It is a clear, colorless liquid (fishy odor), widely used in chemical synthesis, pharmaceutical manufacturing. Because diethylamine (DEA) carries a secondary amine functionality, it is prone under nitrosating conditions (e.g. in presence of nitrite & acidic conditions) to form nitrosamines, notably N‑Nitrosodiethylamine (NDEA), which is a recognized carcinogenic nitrosamine. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) explicitly list NDEA among nitrosamine drug‑substance related impurities (NDSRIs), and set a stringent acceptable intake limit of 26.5 ng/day for NDEA. 

At Manasa Life Sciences, we emphasize nitrosamine‑control readiness by supporting manufacturers and QC labs in identifying and mitigating nitrosamine risk. We supply guidance, perform risk‑assessment of potential nitrosating precursors (such as diethylamine or other secondary amines), and help develop/validate ultra‑sensitive LC‑MS/MS and GC‑MS analytical methods to detect, quantify, and control nitrosamine impurities (like NDEA) ensuring global regulatory compliance and safeguarding patient safety.