Synopsis

Develop and establish the recent past has seen recalls of different small molecule drug products due to the risk of them containing unacceptable levels of nitrosamine impurities. Nitrosamines belong to the larger class of genotoxic impurities (GTI),which are known to be carcinogenic and are potentially mutagenic. This raises a clear need for analytical methods that enable the reliable and fast determination of the most commonly known nitrosamine impurities in an easy and cost-effective manner. Thermo Fisher Scientific presents a simple and fast method, consistent with current FDA recommendations, for the quantitative analysis of 11 nitrosamine components in finished drug product formulations and drug substances. It is based on the High-resolution accurate-mass liquid chromatography mass spectrometry (HRAM LC-MS) methodology and uses Thermo Scientific™ Vanquish™ Flex UHPLC system coupled to a Thermo Scientific™ Q Exactive™ Plus hybrid quadrupole-Orbitrap™ mass spectrometer