Details on multiple impurities (Q&A 10):
The new nitrosamine for testing is N-nitrosodipropylamine (NDPA) with a daily limit of 26,5 ng/day.
To address the limit calculation when more than one nitrosamine is identified in the same product two approaches are possible. Both should not exceed the acceptable risk level of 1:100.000 (see ICH M7(R1) guideline):
However, the approach chosen needs to be justified by the MAH/applicant. The newly added decision tree (Annex 1) should be helpful for further orientation.
All documents and necessary templates can be accessed via the EMA website on nitrosamine impurities.
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