GMP topical

15.01.2025

EMA: Update of Appendix 1 for Nitrosamines

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

11 new nitrosamines have been added and 2 AIs have been updated.

Source:

EMA: Appendix 1 Acceptable intakes established for N-nitrosamines

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