EMA: 14 New Nitrosamines for Appendix 1
Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
14 nitrosamines have been added (e.g. for sumatriptan, roxythromycin and xylomethazoline), and 2 entries relating to previously listed impurities have been updated.
Source:
EMA: What’s new - Appendix 1: Acceptable intakes established for N-nitrosamines
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