Change in criteria for USP dissolution performance verification tests

Walter W. Hauck, Anthony J. DeStefano, William E. Brown, Erika S. Stippler, Darrell R. Abernethy, William F. Koch, Roger L. Williams

Research output: Contribution to journalArticle

Abstract

The US Pharmacopeial Convention has been evaluating its performance verification tests (PVT) for several years. These tests help ensure the integrity of the US Pharmacopeia performance test when a dissolution procedure, as described in General Chapter Dissolution , is relied upon to test a nonsolution orally administered dosage form. One result of the evaluation is a change in the PVT criterion from one based on individual tablet results to one based on the mean and variability of a set of tablets. This paper describes the new PVT and its criterion and how its acceptance limits are derived from results of a collaborative study, explains a two-stage option for the test, and presents operating characteristics.

Original languageEnglish (US)
Pages (from-to)21-26
Number of pages6
JournalAAPS PharmSciTech
Volume10
Issue number1
DOIs
StatePublished - 2009
Externally publishedYes

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Tablets
Pharmacopoeias
Dosage Forms
testing
administered dose

Keywords

  • Acceptance criteria
  • Data analysis
  • Dissolution test
  • Performance verification test
  • Reference standards

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Hauck, W. W., DeStefano, A. J., Brown, W. E., Stippler, E. S., Abernethy, D. R., Koch, W. F., & Williams, R. L. (2009). Change in criteria for USP dissolution performance verification tests. AAPS PharmSciTech, 10(1), 21-26. https://doi.org/10.1208/s12249-008-9169-y

Change in criteria for USP dissolution performance verification tests. / Hauck, Walter W.; DeStefano, Anthony J.; Brown, William E.; Stippler, Erika S.; Abernethy, Darrell R.; Koch, William F.; Williams, Roger L.

In: AAPS PharmSciTech, Vol. 10, No. 1, 2009, p. 21-26.

Research output: Contribution to journalArticle

Hauck, WW, DeStefano, AJ, Brown, WE, Stippler, ES, Abernethy, DR, Koch, WF & Williams, RL 2009, 'Change in criteria for USP dissolution performance verification tests', AAPS PharmSciTech, vol. 10, no. 1, pp. 21-26. https://doi.org/10.1208/s12249-008-9169-y
Hauck WW, DeStefano AJ, Brown WE, Stippler ES, Abernethy DR, Koch WF et al. Change in criteria for USP dissolution performance verification tests. AAPS PharmSciTech. 2009;10(1):21-26. https://doi.org/10.1208/s12249-008-9169-y
Hauck, Walter W. ; DeStefano, Anthony J. ; Brown, William E. ; Stippler, Erika S. ; Abernethy, Darrell R. ; Koch, William F. ; Williams, Roger L. / Change in criteria for USP dissolution performance verification tests. In: AAPS PharmSciTech. 2009 ; Vol. 10, No. 1. pp. 21-26.
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