Nitrosamine and Nitroso-structure impurities acceptable intakes update

Nitrosamines and other nitroso-structure impurities in medicines

We have published updated information for nitrosamine impurities and other nitroso-structure impurities in medicines consistent with recent EMA updated information. The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the AI limit for some impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities and other nitroso-structure 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. This is detailed on the established acceptable intake for nitrosamines in medicines page.

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.