Nitrosamine impurities acceptable intakes update - April 2025

Nitrosamine impurities in medicines

The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include minor editorial amendments and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines. The AI changes are tabulated on the updates to nitrosamines and other nitroso-structures page.

Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities and other nitroso-structure impurities in medicines. 

See our updated information for sponsors and manufacturers and list of established acceptable intake for nitrosamines in medicines and list of established acceptable intake for other nitroso-structures impurities in medicines. Further updated information on this issue will be published as it becomes available.