N-Nitroso Piperazine Dimer

1,4-Dinitrosopiperazine, also known as N,N'-Dinitrosopiperazine or N‑Nitroso Piperazine Dimer, is a nitrosamine impurity of potential toxicological concern. It has the molecular formula C₄H₈N₄O₂, a molecular weight of 144.13g/mol, and is commonly associated with CAS No. 140-79-4. This compound can form under specific chemical conditions involving piperazine derivatives, nitrite sources, and acidic environments during chemical synthesis.

While nitrosamines are generally evaluated under global regulatory bases, including USFDA, EMA, and ICH M7, 1,4-Dinitrosopiperazine is not listed in the FDA’s publicly available tables of nitrosamine impurities. Therefore, there is no officially assigned USFDA acceptable-intake limit or potency category for this compound. Manufacturers are required to assess the risk of formation, implement analytical monitoring (LC-MS/MS, GC-MS), and establish control strategies to minimize potential exposure. If detected, regulatory guidance recommends either generating compound-specific toxicological data or applying read-across from structurally related nitrosamines to justify a safe control limit.

At Manasa Life Sciences, we assist pharmaceutical and chemical manufacturers in managing the potential risk of 1,4-Dinitrosopiperazine formation through comprehensive nitrosamine risk assessments, synthetic-route evaluation, and development of high-sensitivity analytical methods, ensuring regulatory alignment, strong impurity control, and enhanced patient safety throughout the drug development and manufacturing lifecycle.