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Volumn 1121, Issue 1, 2006, Pages 55-63

Uncertainty in liquid chromatographic analysis of pharmaceutical product: Influence of various uncertainty sources

Author keywords

HPLC with UV vis detection; ISO GUM method (approach); Measurand definition; Multiple point calibration; Single point calibration; Uncertainty; Uncertainty budget

Indexed keywords

CALIBRATION; DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; QUALITY CONTROL;

EID: 33744985299     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2006.04.032     Document Type: Article
Times cited : (28)

References (34)
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    • General requirements for the competence of testing and calibration laboratories, ISO/IEC 17025:2000.
  • 4
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    • A large number of very educative examples can be found at the web page of the IMEP intercomparison measurements that are organized by the EC JRC IRMM, http://www.imep.ws/.
  • 18
    • 33745005885 scopus 로고    scopus 로고
    • ISO GUM in Chemistry: Successes and Difficulties. Presented at the workshop "Teaching measurement quality in analytical chemistry", Stockholm, November 17-18, 2004, Available online at http://www.ut.ee/katsekoda/presentations/Leito_TMQAC_2004_presented.pdf.
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    • European Pharmacopoea, fifth ed., Council of Europe, 2004, 47.
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    • The United States Pharmacopoeia/The National Formulary USP 27/NF 22, United States Pharmacopoeial Convention Inc., 2004.
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    • 33744970649 scopus 로고    scopus 로고
    • Extensive discussion of the package is given in the doctoral thesis of R. Kessel, A Novel Approach to Uncertainty Evaluation of Complex Measurements in Isotope Chemistry, Dissertation for the Degree of Doctor in Science, University of Antwerp, 2003, Available online at http://www.metrodata.de/pdf/PhD_Thesis_Ruediger_Kessel_2003.pdf.
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    • OMCL Policy on the Estimation and Application of Uncertainity in Analytical Measurement, European OMCL Network of the Council of Europe, 2003.
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    • The Fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and related Topics, EURACHEM, LGC Teddington, 1998.
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    • WEPAL, International Soil Analytical Exchange, Quarterly Report 2004.3, Wageningen University, 2004.
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    • EA Guidelines on Expression of Uncertainty in Quantitative Testing. Publication Reference EA-4/16, European Cooperation for Accreditation, 2003.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.