N-Nitrosodicyclohexylamine

N,N-Dicyclohexylnitrosamine, also known as N-cyclohexyl-N-nitrosocyclohexanamine, Dicyclohexylnitrosamine, and N-Nitrosodicyclohexylamine, is a high-potency nitrosamine impurity of serious toxicological concern. It has the molecular formula C12H22N2O, a molecular weight of 210.32 g/mol, and is associated with CAS No. 947-92-2. This nitrosamine may form unintentionally during chemical or pharmaceutical manufacturing when cyclic secondary amines particularly cyclohexyl-substituted amines are exposed to nitrite sources under acidic or nitrosating conditions.

N,N-Dicyclohexylnitrosamine is considered a highly carcinogenic nitrosamine. Under the USFDA Carcinogenic Potency Categorization Approach (CPCA), it is classified as Potency Category 1, with an acceptable intake limit of 26.5 ng/day. Regulatory authorities such as the USFDA, EMA, and ICH M7 mandate that manufacturers evaluate potential formation pathways, apply sensitive analytical monitoring (LC-MS/MS, GC-MS), and implement effective control strategies to prevent contamination of APIs, intermediates, excipients, and finished drug products. Although N,N-Dicyclohexylnitrosamine is not intentionally used in pharmaceutical processes, it serves as a valuable reference nitrosamine impurity in risk evaluation, analytical method development, validation, and toxicology studies. Laboratories and quality-control facilities use it to verify method sensitivity, simulate possible nitrosamine formation, and assess process controls in alignment with global regulatory expectations.

At Manasa Life Sciences, we support manufacturers in identifying, assessing, and mitigating the risk of N,N-Dicyclohexylnitrosamine formation through comprehensive nitrosamine risk assessments, synthetic-route analysis, and development of ultra-sensitive analytical methods, ensuring regulatory compliance, strong impurity-control strategies, and enhanced patient and product safety across the manufacturing lifecycle.