Chemistry International Blank Image
Chemistry International Text Image Link to Chemistry International Blank Image Chemistry International Blank Image Chemistry International Blank Image
Chemistry International Blank Image
Chemistry International Blank Image
Chemistry International Text Image Link to Current Issue
Chemistry International Text Image Link to Past Issues
Chemistry International Text Image Link to Officer's Columns
Chemistry International Text Image Link to Features
Chemistry International Blank Image
Chemistry International Text Image Link to Up for Discussion
Chemistry International Text Image Link to IUPAC Wire
Chemistry International Text Image Link to Project Place
Chemistry International Text Image Link to imPACt
Chemistry International Text Image Link to Bookworm
Chemistry International Text Image Link to Internet Connections
Chemistry International Text Image Link to Conference Call
Chemistry International Text Image Link to Where 2B and Y
Chemistry International Text Image Link to Symposia
Chemistry International Text Image Link to CI Indexes
Chemistry International Text Image Link to CI Editor
Chemistry International Text Image Link to Search Function
Chemistry International Text Image Link to Information

 

Chemistry International Text Image Link to Previous Issue Chemistry International Text Image Link to Previous Page Chemistry International Text Image Link to This TOC Chemistry International Text Image Link to Next Page Chemistry International Text Image Link to Next Issue

Vol. 34 No. 6
November-December 2012

Making an imPACt | Recent IUPAC technical reports and recommendations that affect the many fields of pure and applied chemistry.
See also www.iupac.org/publications/pac

IUPAC/CITAC Guide: Investigating Out-of-Specification Test Results of Chemical Composition Based on Metrological Concepts (IUPAC Technical Report)

Ilya Kuselman et al.
Pure and Applied Chemistry, 2012
Vol. 84, No. 9, pp. 1939–1971

A metrological background for investigating out-of-specification (OOS) test results of chemical composition is discussed. When an OOS test result is identified, it is important to determine its root causes and to avoid reoccurrence of such results. An investigation of the causes based on metrological concepts is proposed. It includes assessment of validation data of the measurement process and its metrological traceability chains, evaluation of measurement uncertainty, and related producer’s and consumer’s risks. This approach allows distinguishing between OOS test results that indicate an actual change in chemical composition of an analyzed object, and OOS test results that are metrologically related with a certain confidence probability. Practical examples illustrating applications of the described approach in environmental and food analysis, as well in drug analysis and stability study of drug products, are described. Acceptance limits, warning and action lines for the test results, and corresponding producer’s and consumer’s risks are discussed.

hand.tif http://dx.doi.org/10.1351/PAC-REP-11-10-04


Page last modified 31 October 2012.
Copyright © 2003-2012 International Union of Pure and Applied Chemistry.
Questions regarding the website, please contact edit.ci@iupac.org
Link to CI Home Page Link to IUPAC E-News Link to IUPAC Home Page