Content uniformity and assay requirements in current regulations

Balázs Bánfai, Katalin Ganzler, S. Kemény

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

The acceptance of a tablet batch is based both on the content uniformity test and on the assay. It is shown that these two characteristics are not independent, and the acceptance criteria for them are not even consistent. For content uniformity range three methods of calculation are compared: the present European Pharmacopoeia method, a tolerance range method with improved k tolerance factor and a one-way random effects analysis of variance model. To resolve the inconsistency several options are discussed: applying the holistic content uniformity range alone; using content uniformity standard deviation and assay mean simultaneously or applying a criterion based on Taguchi's quadratic loss function.

Original languageEnglish
Pages (from-to)206-212
Number of pages7
JournalJournal of Chromatography A
Volume1156
Issue number1-2 SPEC. ISS.
DOIs
Publication statusPublished - Jul 13 2007

Fingerprint

Assays
Analysis of variance (ANOVA)
Tablets
Pharmacopoeias
Analysis of Variance

Keywords

  • Acceptance criteria
  • Assay
  • Content uniformity
  • Pharmacopoeia
  • Random effects ANOVA
  • Taguchi's quadratic loss function
  • Tolerance range

ASJC Scopus subject areas

  • Analytical Chemistry

Cite this

Content uniformity and assay requirements in current regulations. / Bánfai, Balázs; Ganzler, Katalin; Kemény, S.

In: Journal of Chromatography A, Vol. 1156, No. 1-2 SPEC. ISS., 13.07.2007, p. 206-212.

Research output: Contribution to journalArticle

Bánfai, Balázs ; Ganzler, Katalin ; Kemény, S. / Content uniformity and assay requirements in current regulations. In: Journal of Chromatography A. 2007 ; Vol. 1156, No. 1-2 SPEC. ISS. pp. 206-212.
@article{4db22efa766f4a6cbf627b344bf80862,
title = "Content uniformity and assay requirements in current regulations",
abstract = "The acceptance of a tablet batch is based both on the content uniformity test and on the assay. It is shown that these two characteristics are not independent, and the acceptance criteria for them are not even consistent. For content uniformity range three methods of calculation are compared: the present European Pharmacopoeia method, a tolerance range method with improved k tolerance factor and a one-way random effects analysis of variance model. To resolve the inconsistency several options are discussed: applying the holistic content uniformity range alone; using content uniformity standard deviation and assay mean simultaneously or applying a criterion based on Taguchi's quadratic loss function.",
keywords = "Acceptance criteria, Assay, Content uniformity, Pharmacopoeia, Random effects ANOVA, Taguchi's quadratic loss function, Tolerance range",
author = "Bal{\'a}zs B{\'a}nfai and Katalin Ganzler and S. Kem{\'e}ny",
year = "2007",
month = "7",
day = "13",
doi = "10.1016/j.chroma.2006.10.067",
language = "English",
volume = "1156",
pages = "206--212",
journal = "Journal of Chromatography",
issn = "0021-9673",
publisher = "Elsevier",
number = "1-2 SPEC. ISS.",

}

TY - JOUR

T1 - Content uniformity and assay requirements in current regulations

AU - Bánfai, Balázs

AU - Ganzler, Katalin

AU - Kemény, S.

PY - 2007/7/13

Y1 - 2007/7/13

N2 - The acceptance of a tablet batch is based both on the content uniformity test and on the assay. It is shown that these two characteristics are not independent, and the acceptance criteria for them are not even consistent. For content uniformity range three methods of calculation are compared: the present European Pharmacopoeia method, a tolerance range method with improved k tolerance factor and a one-way random effects analysis of variance model. To resolve the inconsistency several options are discussed: applying the holistic content uniformity range alone; using content uniformity standard deviation and assay mean simultaneously or applying a criterion based on Taguchi's quadratic loss function.

AB - The acceptance of a tablet batch is based both on the content uniformity test and on the assay. It is shown that these two characteristics are not independent, and the acceptance criteria for them are not even consistent. For content uniformity range three methods of calculation are compared: the present European Pharmacopoeia method, a tolerance range method with improved k tolerance factor and a one-way random effects analysis of variance model. To resolve the inconsistency several options are discussed: applying the holistic content uniformity range alone; using content uniformity standard deviation and assay mean simultaneously or applying a criterion based on Taguchi's quadratic loss function.

KW - Acceptance criteria

KW - Assay

KW - Content uniformity

KW - Pharmacopoeia

KW - Random effects ANOVA

KW - Taguchi's quadratic loss function

KW - Tolerance range

UR - http://www.scopus.com/inward/record.url?scp=34250680185&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34250680185&partnerID=8YFLogxK

U2 - 10.1016/j.chroma.2006.10.067

DO - 10.1016/j.chroma.2006.10.067

M3 - Article

C2 - 17109871

AN - SCOPUS:34250680185

VL - 1156

SP - 206

EP - 212

JO - Journal of Chromatography

JF - Journal of Chromatography

SN - 0021-9673

IS - 1-2 SPEC. ISS.

ER -