ResourceDrug Discovery & Development
Understanding Nitrosamine formation in pharmaceuticals
4 Sept 2025This 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.
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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.NitrosamineDrug Manufacturing