Summary

EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents

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Monitoring and Reporting Work Group

On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline for Residual Solvents”.  This included the revision of Permissible Daily Exposure (PDE) information for Methylisobutylketone contained in the Parent Guideline and includes a PDE for Triethylamine.  Table 2, Table 3 and Appendix 1 of the Parent Guideline have been updated to reflect the revision of the PDE for Triethylamine and Methylisobutylketone.  This revision is effective 14 June 2017.

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