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

doi:10.1208/s12249-008-9169-y

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 journal › Article › peer-review

4 Scopus citations

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 <711>, 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 language	English (US)
Pages (from-to)	21-26
Number of pages	6
Journal	AAPS PharmSciTech
Volume	10
Issue number	1
DOIs	https://doi.org/10.1208/s12249-008-9169-y
State	Published - 2009
Externally published	Yes

Keywords

Acceptance criteria
Data analysis
Dissolution test
Performance verification test
Reference standards

ASJC Scopus subject areas

Pharmaceutical Science

Access to Document

10.1208/s12249-008-9169-y

Cite this

@article{23238d5e2d0b4a889b5ccb355800afee,

title = "Change in criteria for USP dissolution performance verification tests",

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 <711>, 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.",

keywords = "Acceptance criteria, Data analysis, Dissolution test, Performance verification test, Reference standards",

author = "Hauck, {Walter W.} and DeStefano, {Anthony J.} and Brown, {William E.} and Stippler, {Erika S.} and Abernethy, {Darrell R.} and Koch, {William F.} and Williams, {Roger L.}",

year = "2009",

doi = "10.1208/s12249-008-9169-y",

language = "English (US)",

volume = "10",

pages = "21--26",

journal = "AAPS PharmSciTech",

issn = "1530-9932",

publisher = "American Association of Pharmaceutical Scientists",

number = "1",

}

TY - JOUR

T1 - Change in criteria for USP dissolution performance verification tests

AU - Hauck, Walter W.

AU - DeStefano, Anthony J.

AU - Brown, William E.

AU - Stippler, Erika S.

AU - Abernethy, Darrell R.

AU - Koch, William F.

AU - Williams, Roger L.

PY - 2009

Y1 - 2009

N2 - 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 <711>, 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.

AB - 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 <711>, 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.

KW - Acceptance criteria

KW - Data analysis

KW - Dissolution test

KW - Performance verification test

KW - Reference standards

UR - http://www.scopus.com/inward/record.url?scp=67549138283&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67549138283&partnerID=8YFLogxK

U2 - 10.1208/s12249-008-9169-y

DO - 10.1208/s12249-008-9169-y

M3 - Article

C2 - 19132536

AN - SCOPUS:67549138283

SN - 1530-9932

VL - 10

SP - 21

EP - 26

JO - AAPS PharmSciTech

JF - AAPS PharmSciTech

IS - 1

ER -

Change in criteria for USP dissolution performance verification tests

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this