Understanding Nitrosamine formation in pharmaceuticals

This whitepaper from LGC Standards provides a comprehensive overview of nitrosamine and Nitrosamine Drug Substance-Related Impurity (NDSRI) formation in pharmaceuticals. It explores the chemical pathways, contributing factors, and structural features that drive impurity formation during synthesis, formulation, and storage. Key risks include excipient-derived nitrites, aldehydes, peroxides, and API degradation. The guide outlines practical mitigation strategies, such as nitrite scavengers, pH modulation, and excipient optimization, and highlights the importance of supply chain transparency and regulatory alignment. With over 650 nitrosamine reference standards, LGC supports pharmaceutical scientists in impurity profiling and compliance.