Evaluating nitrosamines in drug products has become a big challenge for formulators in the pharmaceutical industry.
When excipients are considered as a potential risk factor during the drug product risk assessment, the risk of the presence of nitrosamines is very low. However, many excipients contain traces of nitrites that can ultimately result in formation of nitrosamines under specific conditions within the drug product.
Two key strategies for nitrosamine risk mitigation are explored in our whitepaper, "Nitrosamines Risk Mitigation: The critical role of excipients and supplier qualification."