Revisoin 7 of ICH Q3C Guideline for Residual Solvents

In October 2018, the ICH Management committee issued Revisoin 7 of ICH Q3C Guideline for Residual Solvents.  The only change is an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol.  The corrected value (3.1 mg/day) was originally published in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.  This value is tighter than the PDE included in the previous revision of ICH Q3C (6.2 mg/day in Rev 6).

EMA and Health Canada have already adopted Revision 7 into local legislation –

EMA – https://www.ema.europa.eu/en/ich-q3c-r7-residual-solvents

Health Canada – https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/notice-impurities-guideline-residual-solvents.html

Additionally, the ICH Management committee approved the publication of Support Documents 1, 2 and 3, which include the summaries of the toxicity data from which PDEs were derived (https://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-residual-solvents.html).

Click Here to View Official Publication