Determination of nitrosamine impurities using the Agilent 6475 Triple Quadrupole LC/MS system

Nitrosamine impurities are by-products that are produced in trace amounts during the manufacturing process of pharmaceutical drugs. These impurities are classified as potentially genotoxic impurities and probable carcinogens with long-term intake. Therefore, it is important to determine their levels in final drug products with a high level of sensitivity and confidence. In this application note, Agilent Technologies evaluates the quantification performance of eight nitrosamine impurities using the Agilent 6475 Triple Quadrupole LC/MS (LC/TQ) system coupled with the Agilent 1290 Infinity II Bio LC system and atmospheric pressure chemical ionization (APCI) source.