N-Nitrosopiperidine

N-Nitrosopiperidine, also known as 1-nitrosopiperidine, is a highly potent nitrosamine impurity of significant toxicological concern. It has the molecular formula C5H10N2O, a molecular weight of 114.15 g/mol, and is associated with CAS No. 100-75-4. This nitrosamine can form unintentionally during chemical synthesis or pharmaceutical manufacturing when piperidine or piperidine derivatives are exposed to nitrite sources under acidic or nitrosating conditions.

N-Nitrosopiperidine is classified as a highly carcinogenic nitrosamine. According to the USFDA Carcinogenic Potency Categorization Approach (CPCA), it is assigned Potency Category 1, with a recommended acceptable intake limit of 26.5 ng/day. Global regulatory bases, including the FDA, EMA, and ICH M7, require manufacturers to assess the risk of formation, implement high-sensitivity analytical monitoring (LC-MS/MS, GC-MS), and establish strong control strategies to prevent contamination in APIs, intermediates, excipients, and finished drug products. Although N-Nitrosopiperidine is not intentionally used in pharmaceutical production, it is employed as a reference nitrosamine impurity in risk assessment studies, analytical method development, and validation. It is commonly used in laboratories and quality control to simulate potential formation, confirm detection limits, and evaluate process controls according to regulatory requirements.

At Manasa Life Sciences, we support manufacturers in identifying, evaluating, and controlling the risk of N-Nitrosopiperidine formation through comprehensive nitrosamine risk assessments, process evaluation, and development of ultra-sensitive analytical methods, ensuring regulatory compliance, strong impurity control, and enhanced patient safety throughout the drug development and manufacturing lifecycle.