Ensuring Pharmaceutical Safety: Mass Spectrometry Approaches to Nitrosamine Analysis
Nitrosamine impurities present a significant challenge for pharmaceutical manufacturers, requiring highly sensitive analytical methods capable of detecting trace levels in drug products. This piece explores how Almac Sciences uses advanced mass spectrometry techniques to support nitrosamine analysis, including the development and validation of a robust LC-QQQ-MS method. It demonstrates how a GMP-compliant approach can provide accurate, repeatable quantitation at very low levels, supporting effective impurity monitoring and pharmaceutical safety.
Read the full piece to discover how advanced mass spectrometry techniques can support sensitive and reliable nitrosamine analysis.