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Traceability without uncertainty: current situation in the pharmaceutical industry

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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.

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Authors and Affiliations

  1. The National Physical Laboratory of Israel (INPL), Givat Ram, 91904, Jerusalem , Israel

    Ilya Kuselman

  2. ChemAgis Ltd., P.O.Box 9091, 61090, Tel-Aviv, Israel

    Alexander Weisman

  3. Department of General and Analytical Chemistry, University of Leoben, Franz-Josef Strasse 18, 8700, Leoben, Austria

    Wolfhard Wegscheider

Authors
  1. Ilya Kuselman
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  2. Alexander Weisman
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  3. Wolfhard Wegscheider
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Correspondence to Ilya Kuselman.

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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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Kuselman, I., Weisman, A. & Wegscheider, W. Traceability without uncertainty: current situation in the pharmaceutical industry. Accred Qual Assur 8, 530–531 (2003). https://doi.org/10.1007/s00769-003-0686-9

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  • DOI: https://doi.org/10.1007/s00769-003-0686-9

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