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Content Uniformity and Assay Requirements in Current Regulations by Balázs Bánfai; Katalin Ganzler; Sándor Kemény is a Chemistry article available to read on EtoBox.

What is Content Uniformity and Assay Requirements in Current Regulations about?

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.

Who reads Content Uniformity and Assay Requirements in Current Regulations?

Author

Balázs Bánfai; Katalin Ganzler; Sándor Kemény

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 1873-3778)

Published

2007

Language

EN

Field

Chemistry (Physical Sciences)