Literature DB >> 6620145

Systematic error associated with apparatus 2 of the USP dissolution test III: limitations of calibrators and the USP suitability test.

D C Cox, W B Furman, L K Thornton, T W Moore, E H Jefferson.   

Abstract

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.

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Year:  1983        PMID： 6620145     DOI： 10.1002/jps.2600720817

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN： 0022-3549            Impact factor:   3.534


  2 in total

1.  Gastroretentive drug delivery system of carbamazepine: formulation optimization using simplex lattice design: a technical note.

Authors:  Dasharath M Patel; Natvarlal M Patel; Nitesh N Pandya; Pranav D Jogani
Journal:  AAPS PharmSciTech       Date:  2007-02-09       Impact factor: 3.246

2.  Velocity distribution and shear rate variability resulting from changes in the impeller location in the USP dissolution testing apparatus II.

Authors:  Ge Bai; Piero M Armenante
Journal:  Pharm Res       Date:  2007-11-27       Impact factor: 4.200
  2 in total

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