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.

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.