Document Detail


Systematic error associated with apparatus 2 of the USP dissolution test III: limitations of calibrators and the USP suitability test.
MedLine Citation:
PMID:  6620145     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The calibrator tablets now used in the USP suitability test do not reveal common sources of systematic error associated with Apparatus 2. When the apparatus was operated under conditions near or beyond USP tolerances, changes in the results of the USP calibrators were slight, whereas those of several samples of commercial prednisone tablets were significant. Thus, the USP calibrators and requirements do not guarantee suitability of the equipment for general dissolution testing of drug products.
Authors:
D C Cox; W B Furman; L K Thornton; T W Moore; E H Jefferson
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  72     ISSN:  0022-3549     ISO Abbreviation:  J Pharm Sci     Publication Date:  1983 Aug 
Date Detail:
Created Date:  1983-11-23     Completed Date:  1983-11-23     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  910-3     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Chemistry, Pharmaceutical / instrumentation*
Pharmacopoeias as Topic
Solubility*
Tablets
United States
Chemical
Reg. No./Substance:
0/Tablets

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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