ICH Q3C: New Version of the Guideline for Residual Solvents published

Since the end of April 2024, the ninth revision of the "IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R9)" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) has been available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adjustments in section 3.4 Analytical Procedures.

The updated section 3.4 Analytical Procedures now states as follows:

"Residual solvents are typically determined using chromatographic techniques such as gas chromatography. Any harmonised procedures for determining levels of residual solvents as described in the pharmacopoeias should be used, if feasible. Otherwise, manufacturers would be free to select the most appropriate validated analytical procedure for a particular application. If only Class 3 solvents are present, a non-specific method such as loss on drying may be used, if the method is properly validated. The impact of solvent volatility on the test method should be
considered in the validation.
Validation of methods for residual solvents should conform to the current version of ICH guideline Q2 on Validation of Analytical Procedures."

The "IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R9)" and all other valid "Quality (Q)-Guidelines" can be found on the ICH website.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.