Uncertainty budget for final assay of a pharmaceutical product based on RP-HPLC

Research output: Contribution to journalConference article – Annual report year: 2003Researchpeer-review

  • Author: Heydorn, Kaj

    Department of Chemistry, Technical University of Denmark

  • Author: Anglov, Thomas

    Novo Nordisk A/S

  • Author: Byrialsen, Kirsten

    Novo Nordisk A/S

  • Author: Carstensen, Jan Karkov

    Novo Nordisk A/S

  • Author: Christensen, Finn

    Novo Nordisk A/S

  • Author: Christensen, Steen

    Novo Nordisk A/S

  • Author: Madsen, Birger Stjernholm

    Novo Nordisk A/S

  • Author: Sørensen, Else

    Novo Nordisk A/S

  • Author: Sørensen, Jeanett Norrbohm

    Novo Nordisk A/S

  • Author: Toftegård, Karin

    Novo Nordisk A/S

  • Author: Winther, Henrik

    Novo Nordisk A/S

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Compliance with specified limits for the content of active substance in a pharmaceutical drug requires knowledge of the uncertainty of the final assay. The uncertainty of measurement is based on the ISO recommendation as expressed in the Guide to the Expression of Uncertainty in Measurement (GUM). The reported example illustrates the estimation of uncertainty for the final determination of a protein concentration by HPLC using UV detection, using the approach described by EURACHEM/CITAC. The combined standard uncertainty for a protein concentration of 2400 mumol/L was estimated to be 14 mumol/L. All known and potential uncertainty components are presented in Ishikawa diagrams and were carefully evaluated using Type A or Type B estimates. Special efforts were made to avoid duplication or omission of significant contributions to the combined uncertainty. Hence, before accepting the uncertainty budget, the estimated combined standard uncertainty was verified using the variation observed in a number of quality control samples.
Original languageEnglish
JournalAccreditation and quality assurance
Volume8
Issue number5
Pages (from-to)225-230
ISSN0949-1775
DOIs
Publication statusPublished - 2003
EventInteract 2002 Conference: Metrology in Chemistry - Sydney, Australia
Duration: 22 Jul 200225 Jul 2002

Conference

ConferenceInteract 2002 Conference
CountryAustralia
CitySydney
Period22/07/200225/07/2002
CitationsWeb of Science® Times Cited: No match on DOI

    Research areas

  • Uncertainty budget, HPLC, Drug assay, Validation, Data, Verification
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