These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Content uniformity and assay requirements in current regulations.
    Author: Bánfai B, Ganzler K, Kemény S.
    Journal: J Chromatogr A; 2007 Jul 13; 1156(1-2):206-12. PubMed ID: 17109871.
    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.
    [Abstract] [Full Text] [Related] [New Search]