n-nitrosodimethylamine

N-Nitrosodimethylamine (CAS 62-75-9), commonly abbreviated as NDMA, is a nitrosamine compound used as a reference standard and analytical reagent in pharmaceutical and life sciences research.

Where is n-nitrosodimethylamine used?

• Pharmaceutical QA: reference standard to detect and quantify nitrosamine impurities in active pharmaceutical ingredients and finished drug products for safety compliance
• Analytical method development: validation of HPLC, GC-MS, and LC-MS/MS procedures
• Biotechnology and life sciences research: positive control in genotoxicity and mutagenicity assays, including Ames tests and in vitro studies
• Contract testing laboratories require certified reference materials with traceable purity documentation.

Good to know: Testing is performed in compliance with ICH M7 and regulatory guidance from FDA and EMA. Supply is restricted to qualified pharmaceutical and research buyers with authorization.

Commercial specifications

• Certified reference standard, typically neat liquid or in solution at defined concentrations in appropriate solvents
• Certificates of analysis confirming purity