Risk control for nitrosamine impurities in drug products is a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and the rate of reaction often control the build-up of nitrosamine.
This white paper explores the impact of excipient selection on the level of nitrosamine formed, showing that changing the supplier of a single excipient, or of the three most critical excipients, can reduce nitrosamine formation by up to 59% and 89%, respectively.
Finally, it includes an open-access tool that enables users to calculate the theoretical formation of nitrosamines in their specific formulations. This calculation template can be used for (i) the preliminary screening of the risk of nitrosamine formation in drug products and (ii) the preliminary assessment of the impact of excipient selection for risk mitigation.
