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22.02.2024

ICH: Revision 9 of ICH Q3C Guideline Finalised

The ICH Q3C “Guideline for Residual Solvents” has undergone revision to become finalised as version R9 using the Minor Revision Procedure. This revised document was published on 24 January 2024 and reached Step 4 of the ICH Process, which is the adoption of a harmonised guideline.

The purpose of this minor revision was to include consideration for solvent volatility in analytical methods.

The Q3C ICH Guideline was first published in 1997 and provides recommendations on using less toxic solvents in drug substance manufacturing, as well as setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

Source:

ICH: News

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