Nitrosamine impurities acceptable intakes update

Nitrosamines in medicines

The TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent European Medicines Agency updated information [xlsx, 2.41 KB]. The changes include minor editorial amendments, increases to the AI limit for a nitrosamine impurity 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 acceptable intakes (AI) for nitrosamine impurities in medicines that we consider acceptable. This is detailed on the TGA website.

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