Nitrosamine impurities in medicines
The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information – external site. The changes include minor editorial amendments and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines. The AIs are tabulated on the TGA website.
Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities and other nitroso-structure impurities in medicines. This is detailed on the TGA website.
Visit the TGA website for the updated information for sponsors and manufacturers, list of established acceptable intake for nitrosamines in medicines and list of established acceptable intakes for other nitroso-structure impurities in medicines. Further updated information on this issue will be published as it becomes available.
