Pyrrolidine/ NPYR starting material

Pyrrolidine (NPYR / Azacyclopentane / Butylenimine) is a simple secondary amine with molecular formula C4H9N and a molecular weight of 71.12 g/mol. Its CAS number is 123-75-1. While Pyrrolidine itself is not a nitrosamine impurity, it is recognized as a common starting material / precursor in the synthesis of active pharmaceutical ingredients (APIs)  and under certain conditions (e.g. exposure to nitrosating agents, nitrites, acidic medium) it can be nitrosated to form a potent nitrosamine impurity: N‑Nitrosopyrrolidine. Because of this potential, Pyrrolidine is relevant in global nitrosamine risk‑management bases (e.g. those defined by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and guidelines such as ICH M7) which require manufacturers of APIs and drug products to evaluate and control nitrosamine formation when precursors like Pyrrolidine are used. 

At Manasa Life Sciences, we recognize the critical role of precursor amines such as Pyrrolidine in nitrosamine risk and offer support to manufacturers through comprehensive risk assessments, guidance for manufacturing controls, and development/validation of ultra‑sensitive analytical methods (LC‑MS/MS, GC‑MS) to detect and quantify nitrosamines (e.g. N‑Nitrosopyrrolidine) that may form from such precursors. This helps ensure compliance with global regulatory expectations, supports safe API development, and protects patient safety by minimizing nitrosamine exposure risk.