The detection of N-nitrosamine impurities in medicines and the increasing presence of nitrosamine drug substance-related impurities (NDSRIs) have presented significant challenges for both drug manufacturers and regulatory agencies.
Understanding the conditions that lead to nitrosamine formation is crucial for reducing their presence in our food. This article explores the science behind nitrosamine formation in cured meats and offers practical tips for minimizing their levels, ensuring a safer and healthier diet.
Implementing effective strategies involves six crucial steps: conducting thorough risk assessments, optimizing manufacturing processes, using high-purity raw materials, performing rigorous analytical testing, adhering to regulatory guidelines, and maintaining continuous monitoring and quality control. These measures collectively minimize nitrosamine risks in pharmaceuticals, ensuring safer medicines for consumers
