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Analytical method development in the quality by design framework
Karlstad University, Faculty of Health, Science and Technology (starting 2013), Department of Engineering and Chemical Sciences (from 2013).ORCID iD: 0000-0001-8561-6872
AstraZeneca R and D, Mölndal, Sweden.
Karlstad University, Faculty of Health, Science and Technology (starting 2013), Department of Engineering and Chemical Sciences (from 2013).ORCID iD: 0000-0003-1819-1709
Poland.
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2014 (English)In: American Laboratory, ISSN 0044-7749, Vol. 46, no 9, p. 12-15Article in journal (Refereed) Published
Resource type
Text
Abstract [en]

The development of analytical methods in the Quality by Design (QbD) framework is currently gaining great momentum in the pharmaceutical industry. Presented here is a case study in which a pharmaceutical Quality Control (QC) method was developed using HPLC. The possibilities of continuous improvements during the method’s lifetime are demonstrated by switching to ultrahigh performance liquid chromatography (UHPLC).

Place, publisher, year, edition, pages
AMERICAN LABORATORY-LABCOMPARE , 2014. Vol. 46, no 9, p. 12-15
Keywords [en]
analytic method; Article; drug industry; high performance liquid chromatography; particle size; quality control; temperature; ultra performance liquid chromatography
National Category
Chemical Engineering
Research subject
Chemical Engineering
Identifiers
URN: urn:nbn:se:kau:diva-42474ISI: 000345735800004Scopus ID: 2-s2.0-84940426411OAI: oai:DiVA.org:kau-42474DiVA, id: diva2:931252
Funder
Swedish Research CouncilAvailable from: 2016-05-27 Created: 2016-05-23 Last updated: 2019-11-06Bibliographically approved

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Scopushttp://www.americanlaboratory.com/914-Application-Notes/169223-Analytical-Method-Development-in-the-Quality-by-Design-Framework/

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Åsberg, DennisSamuelsson, JörgenFornstedt, Torgny

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