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ICH Q3C Maintenance Procedures
for the
Guidance for Industry Q3C Impurities:
Residual Solvents
The International Conference on
Harmonisation (ICH) has developed maintenance procedures for revising the
permitted daily exposure (PDE) of solvents included in the guidance for industry
Q3C Impurities:
Residual Solvents. A list of these solvents was included in the guidance, but is now a
companion guidance called Q3C Tables and List [Word]
or [PDF] (Posted
11/12/2003)
This web page makes available to the public all recommendations, decisions, and other
information related to the revision of the tables and list.
Maintenance Process
Recommendations for Revision to the
List
- Tetrahydrofuran (THF)
- N-Methylpyrrolidone (NMP)
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FDA/Center for Drug Evaluation and Research
Created: June 3, 2002, Updated May 7, 2004
Originator: OTCOM/DLIS
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