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GUIDANCE DOCUMENT

Q3C Tables and List Rev. 4 August 2018

Final
Docket Number:
Not found
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This is the companion document for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance for industry Q3C Impurities: Residual Solvents, which makes recommendations as to what amounts of residual solvents are considered safe in pharmaceuticals.


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All written comments should be identified with this document's docket number: Not found.

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