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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.
AstraZeneca R and D, Mölndal, Sweden.
Karlstad University, Faculty of Health, Science and Technology (starting 2013), Department of Engineering and Chemical Sciences.ORCID iD: 0000-0003-1819-1709
Poland.
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2015 (English)In: American Pharmaceutical Review, ISSN 1099-8012, Vol. 18, no 2Article in journal (Refereed) PublishedText
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
Russell House Publishing, 2015. Vol. 18, no 2
Keyword [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-42474ScopusID: 2-s2.0-84940426411OAI: oai:DiVA.org:kau-42474DiVA: diva2:931252
Funder
Swedish Research Council
Available from: 2016-05-27 Created: 2016-05-23 Last updated: 2016-11-24Bibliographically 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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