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Q3C(R8) Adoption of Part VI of Q3C(R8) (PDEs for 2-MTHF, CPME, TBA) by the Regulatory Members of the ICH Assembly under Step 4

The ICH Q3C(R8) Residual Solvents guideline has been updated and Permitted Daily Exposure (PDE) values have been added for the following substances:

• 2-methyltetrahydrofuran (50 mg/day)
• Cyclopentyl methyl ether (15 mg/day)
• Tertiary butyl alcohol (35 mg/day)

These values has been developed by the appropriate ICH Expert Working Group (EWG) based on the toxicity details.

On March 25, 2020, ICH had already published the document open for public consultation (Step 2). The proposed values were then adopted as final and included in the final draft of the document (step 4). This will allow for adoption by the regulatory parties of ICH regions, in accordance with the ICH Process (step 5), concluding the review.

For the original document, please see link below.