After the discovery of unacceptable levels of nitrosamine contaminations in certain drug products, regulatory agencies around the world have mandated stringent guidelines and analytical testing of all pharmaceuticals, especially chemically synthesized ones, to control and limit the level of these genotoxic impurities in drugs. To ensure patient health and safety, pharmaceutical manufacturers must develop highly selective and sensitive methods to meet these requirements.
View this info kit to learn how to:
- Eliminate false positives and screen samples with confidence
- Assess the potential of nitrosamine formation in your drug product
- Develop ion chromatography methods for amine determination in a pharmaceutical sample