Wednesday 25 November 2020

ICH guideline Q3D (R2) on elemental impurities Step 2b


This document is out for public consultation. The doucment is comprised of extracts of the Q3D(R2) Guideline with the revisions to the Q3D(R1) Guideline • Part 1 - Extract of Appendix 2: Correction of PDEs for Gold, Silver and Nickel  • Part 2 - Extract of Appendix 3: Correction of Gold monograph  • Part 3 - Extract of Appendix 3: Correction of Silver monograph  • Part 4 - New Appendix 5.


For details, see:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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