Traceability without uncertainty: current situation in the pharmaceutical industry |
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Authors: | Email author" target="_blank">Ilya?KuselmanEmail author Alexander?Weisman Wolfhard?Wegscheider |
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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 |
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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. |
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Keywords: | Traceability Measurement uncertainty Reference materials Quality of analytical results |
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