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Analytical method development in the quality by design framework
Karlstads universitet, Fakulteten för hälsa, natur- och teknikvetenskap (from 2013), Institutionen för ingenjörs- och kemivetenskaper (from 2013).ORCID-id: 0000-0001-8561-6872
AstraZeneca R and D, Mölndal, Sweden.
Karlstads universitet, Fakulteten för hälsa, natur- och teknikvetenskap (from 2013), Institutionen för ingenjörs- och kemivetenskaper (from 2013).ORCID-id: 0000-0003-1819-1709
Poland.
Vise andre og tillknytning
2014 (engelsk)Inngår i: American Laboratory, ISSN 0044-7749, Vol. 46, nr 9, s. 12-15Artikkel i tidsskrift (Fagfellevurdert) Published
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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).

sted, utgiver, år, opplag, sider
AMERICAN LABORATORY-LABCOMPARE , 2014. Vol. 46, nr 9, s. 12-15
Emneord [en]
analytic method; Article; drug industry; high performance liquid chromatography; particle size; quality control; temperature; ultra performance liquid chromatography
HSV kategori
Forskningsprogram
Kemiteknik
Identifikatorer
URN: urn:nbn:se:kau:diva-42474ISI: 000345735800004Scopus ID: 2-s2.0-84940426411OAI: oai:DiVA.org:kau-42474DiVA, id: diva2:931252
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Swedish Research CouncilTilgjengelig fra: 2016-05-27 Laget: 2016-05-23 Sist oppdatert: 2019-11-06bibliografisk kontrollert

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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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