INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR
PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED GUIDELINE
IMPURITIES : G UIDELINE FOR R ESIDUAL SOLVENTS
Q3C (R 9)
Current Step 4 version
dated 22 April 2021
This Gui deline has been developed by the appropriate ICH Expert Working Group and has been
subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4
of the Process the final draft is recommended for adoption to the regulator y bodies of ICH
regions.
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