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Traceability without uncertainty: current situation in the pharmaceutical industry
Authors:Email author" target="_blank">Ilya?KuselmanEmail author  Alexander?Weisman  Wolfhard?Wegscheider
Institution:(1) The National Physical Laboratory of Israel (INPL), Givat Ram, 91904 Jerusalem , Israel;(2) ChemAgis Ltd., P.O.Box 9091, 61090 Tel-Aviv, Israel;(3) Department of General and Analytical Chemistry, University of Leoben, Franz-Josef Strasse 18, 8700 Leoben, Austria
Abstract:The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is necessary for understanding the level of confidence of the analytical results and their comparability, particularly during preparation and characterisation of the reference standards.Papers published in this section do not necessarily reflect the opinion of the Editors, the Editorial Board and the Publisher. Apart from exceptional circumstances, they are not submitted to the usual referee procedure and go essentially unaltered.
Keywords:Traceability  Measurement uncertainty  Reference materials  Quality of analytical results
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