TGA
Nitrosamines in medicines
The TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent . 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 that we consider acceptable.
Visit the page for the updated list of established acceptable intake for nitrosamines in medicines. Updated information on this issue will be published as it becomes available.
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