Document Detail


International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice.
MedLine Citation:
PMID:  22379689     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  77     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-03-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  10754-5     Citation Subset:  T    
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