Dipropylamine / NDPA Starting material

Dipropylamine (also known as Di-n-propylamine, Dipropanamine, Dipropylamine (8CI), N,N-Di(n-propyl)amine, N,N-Dipropylamine, N-Propyl-1-propanamine, n-Dipropylamine) is a secondary aliphatic amine with the molecular formula C₆H₁₅N, molecular weight 101.19 g/mol, and CAS number 142-84-7. It is widely used as a versatile starting material and intermediate in the synthesis of pharmaceuticals and specialty fine chemicals. Although Dipropylamine itself is not a nitrosamine impurity, it can undergo nitrosation in the presence of nitrite sources or acidic nitrosating conditions to form N-Nitrosodi-n-propylamine (NDPA)  a nitrosamine of toxicological concern. As a result, Dipropylamine is included in global nitrosamine risk-assessment bases established by regulatory authorities such as the U.S. FDA, EMA, and ICH M7, which require manufacturers to evaluate, monitor, and control the potential formation of NDPA during API and drug-product manufacturing.

At Manasa Life Sciences, we emphasize stringent quality controls around amine-based starting materials like Dipropylamine. Our support includes comprehensive nitrosamine risk assessment, detailed review of manufacturing routes, evaluation of nitrite/nitrosation risk factors, and development of ultra-sensitive analytical methods (LC-MS/MS, GC-MS) capable of detecting NDPA at trace levels. Through strong process understanding and advanced analytical capabilities, we ensure that our materials comply with global regulatory expectations and support safe, reliable, and contamination-free API manufacturing.