ICH guideline Q3C (R8) on impurities: guideline for residual solvents

We have adopted this International Scientific Guideline - ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 20 November 2021

Replaces: ICH Q3C (R6); EMA/CHMP/ICH/82260/2006 (adopted by the TGA on 8 June 2023)

Categories: ICH | Quality | Impurities

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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