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

Published/Copyright: November 1, 2012
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Chemistry International -- Newsmagazine for IUPAC
From the journal Chemistry International -- Newsmagazine for IUPAC Volume 34 Issue 6

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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.

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

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Page last modified 31 October 2012.

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Published Online: 2012-11-01
Published in Print: 2012-11

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  2. From the Editor
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  4. Our Roles, Responsibilities, and Legacy
  5. New Exhibit Shows the Influence of Alchemy on Modern Chemistry
  6. The European Chemicals Agency Experience
  7. IUPAC at the Helsinki Chemical Forum
  8. A Cross-Disciplinary, Multiclass Educational Project
  9. ICSTI at Work
  10. Young Chemists to the 44th IUPAC Congress
  11. John D. Petersen Appointed IUPAC Executive Director
  12. Mozambique and Argentina Join IUPAC as Full Members
  13. Winners of 2012 IUPAC Prizes for Young Chemists
  14. Rachel O’Reilly Receives the 2012 IUPAC-Samsung Young Polymer Scientist Award
  15. Second CHEMRAWN VII Prize Awarded to Rashmi Sanghi
  16. Ian Mills Awarded IUPAP SUNAMCO Prize
  17. Mark Cesa and James Economy Named ACS Fellows
  18. IUPAC Safety Training Program
  19. InChIs and Registry Numbers
  20. Guidelines for Reporting of Phase Equilibrium Measurements (IUPAC Recommendations 2012)
  21. Characterization of Photoluminescence Measuring Systems (IUPAC Technical Report)
  22. IUPAC/CITAC Guide: Investigating Out-of-Specification Test Results of Chemical Composition Based on Metrological Concepts (IUPAC Technical Report)
  23. A Brief Guide to Polymer Nomenclature
  24. IUPAC-NIST Solubility Data Series–Recent Volumes
  25. Going for Gold: The 44th International Chemistry Olympiad
  26. On the Description of Nanomaterials
  27. What’s in a Name? Possibly Death and Taxes!
  28. IUPAC MACRO World Polymer Congress 2012
  29. Analytical Chemistry in Africa
  30. Polymer
  31. Solution Chemistry
  32. Polymer Spectroscopy
  33. Grignard’s Gift to Chemistry
  34. Mark Your Calendar
  35. Index for 2012
https://doi.org/10.1515/ci.2012.34.6.25a

Articles in the same Issue

  1. Masthead
  2. From the Editor
  3. Contents
  4. Our Roles, Responsibilities, and Legacy
  5. New Exhibit Shows the Influence of Alchemy on Modern Chemistry
  6. The European Chemicals Agency Experience
  7. IUPAC at the Helsinki Chemical Forum
  8. A Cross-Disciplinary, Multiclass Educational Project
  9. ICSTI at Work
  10. Young Chemists to the 44th IUPAC Congress
  11. John D. Petersen Appointed IUPAC Executive Director
  12. Mozambique and Argentina Join IUPAC as Full Members
  13. Winners of 2012 IUPAC Prizes for Young Chemists
  14. Rachel O’Reilly Receives the 2012 IUPAC-Samsung Young Polymer Scientist Award
  15. Second CHEMRAWN VII Prize Awarded to Rashmi Sanghi
  16. Ian Mills Awarded IUPAP SUNAMCO Prize
  17. Mark Cesa and James Economy Named ACS Fellows
  18. IUPAC Safety Training Program
  19. InChIs and Registry Numbers
  20. Guidelines for Reporting of Phase Equilibrium Measurements (IUPAC Recommendations 2012)
  21. Characterization of Photoluminescence Measuring Systems (IUPAC Technical Report)
  22. IUPAC/CITAC Guide: Investigating Out-of-Specification Test Results of Chemical Composition Based on Metrological Concepts (IUPAC Technical Report)
  23. A Brief Guide to Polymer Nomenclature
  24. IUPAC-NIST Solubility Data Series–Recent Volumes
  25. Going for Gold: The 44th International Chemistry Olympiad
  26. On the Description of Nanomaterials
  27. What’s in a Name? Possibly Death and Taxes!
  28. IUPAC MACRO World Polymer Congress 2012
  29. Analytical Chemistry in Africa
  30. Polymer
  31. Solution Chemistry
  32. Polymer Spectroscopy
  33. Grignard’s Gift to Chemistry
  34. Mark Your Calendar
  35. Index for 2012
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