Cause of high variability in drug dissolution testing and its impact on setting tolerances

European Journal of Pharmaceutical Sciences

Volumn 12, Issue 3, 2001, Pages 271-276

  Qureshi, Saeed A ^b   Shabnam, Javad ^a  

^a Health Canada and World Health Organization Collaborating Center for Standardization and Evaluation of Biologicals   (Canada)

^b Banting Research Centre   (Canada)

Author keywords

Amoxicillin capsules; Drug dissolution testing; Glibenclamide glyburide tablets; Setting dissolution specifications; US FDA prednisone tablets; USP calibrator tablets

Indexed keywords

AMOXICILLIN; GLIBENCLAMIDE; METAL; PREDNISONE; SALICYLIC ACID;

APPARATUS; ARTICLE; CALIBRATOR; CONTROLLED STUDY; DISSOLUTION; DRUG CAPSULE; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; PRIORITY JOURNAL; SPECTROPHOTOMETER; TABLET DISINTEGRATION; VESSEL;

EID: 0033674245     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0928-0987(00)00174-3     Document Type: Article

References (16)

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6. Systematic Error Associated with Apparatus 2 of the USP dissolution test V interaction of two tableted prednisone formulations with glass and plastic vessels
7. Calibration of dissolution apparatuses 1 and 2 -- What to do when equipment fails
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10. Dissolution testing: Collaborative study of the in-house NCDA 2 dissolution calibrator tablets with USP apparatus 2
11. A Critical Assessment of the USP Dissolution Apparatus Suitability Test Criteria
12. Assessment of pharmaceutical quality of furosemide tablets from multinational markets
13. Typical variability in drug dissolution testing: Study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product
14. The USP dissolution calibrator tablet collaborative study -- an overview of the 1996 process