Nitrosamine impurities acceptable intakes update - October 2024

Nitrosamines in medicines

We have published updated acceptable intake (AI) information for nitrosamine 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 nitrosamine impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.

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

Visit the TGA website for the updated information for sponsors and manufacturers and list of established acceptable intake for nitrosamines in medicines. Further updated information on this issue will be published as it becomes available.