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U.S. Department of Health and Human Services

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ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

The International Conference on Harmonisation (ICH) has developed maintenance procedures  (PDF - 26KB) for revising the permitted daily exposure (PDE) of solvents included in the Q3C guidance

This web page makes available to the public all recommendations, decisions, and other information related to the revision of the Q3C tables and list (PDF - 183KB). 

Draft Recommendations for Revision to the List

 

Final Recommendations for Revision to the List