Diethanolamine / NDELA Starting material

2,2-Iminodiethanol, also known as N,N-Bis(2-hydroxyethyl)amine or Diethanolamine (DEA), is a versatile amino alcohol widely used as a starting material and intermediate in pharmaceutical, personal-care, and industrial chemical synthesis. Diethanolamine has the molecular formula C₄H₁₁NO₂, a molecular weight of 105.14 g/mol, and is identified by CAS No. 111-42-2. As a secondary amine containing two hydroxyethyl groups, DEA can participate in a wide range of chemical transformations. Although Diethanolamine itself is not a nitrosamine impurity, it can undergo nitrosation when exposed to nitrite sources or acidic nitrosating conditions, leading to formation of N-Nitrosodiethanolamine (NDELA) a nitrosamine of regulatory concern. Due to this potential, DEA is included in global nitrosamine risk-management bases defined by the U.S. FDA, EMA, and ICH M7, which require manufacturers to evaluate and control nitrosamine formation when using secondary amine starting materials.

At Manasa Life Sciences, we support pharmaceutical and chemical manufacturers by providing comprehensive nitrosation risk assessments, evaluation of process conditions that may contribute to NDELA formation, and development and validation of ultra-sensitive analytical methods (LC-MS/MS, GC-MS) capable of detecting NDELA at trace levels. Our expertise ensures full alignment with global nitrosamine guidelines, enhances impurity control strategies, and strengthens product quality and safety across the entire development and manufacturing lifecycle.