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GUIDANCE DOCUMENT

Q3C Tables and List Rev. 4 August 2018

Download the Final Guidance Document
Final
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.

 

Companion document to Q3C Impurities: Residual Solvents

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

 
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