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ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities

The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new permitted daily exposure (PDE) limits for seven DNA-reactive substances to control their carcinogenic risk.


The rationale for including the new mutagenic impurities along with their supporting monographs are discussed in this guideline.


The seven newly added impurities, along with their permitted daily exposure (PDE) levels, are as shown below:

A PowerPoint presentation deck was also released along with the M7(R2) guideline to summarize the vast guideline.


The newly released guideline is now at Step 2 of the ICH process and the draft is open for public comment.

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