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.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.