Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline

Edlinger I.; Liebenberger I.; Macas R.; Mayrhofer A.; Stouer S.; Wirthumer-Hoche C.

doi:10.3797/scipharm.aut-02-02

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Article

10 January 2002

Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline

and

Bundesinstitut für Arzneimittel (BIfA), Zimmermanngasse 3, A-I095 Wien

Bundesministerium für soziale Sicherheit und Generationen, Radetzkystr. 2, A-I 030 Wien

Authors to whom correspondence should be addressed.

Sci. Pharm.2002, 70(1), 15-24;https://doi.org/10.3797/scipharm.aut-02-02

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Abstract

The in-use stability of 25 drug products (oralliquids) with sensitive active ingredients was tested with a new test design simulating the stress of practical use. The results showed in so me cases a dramatic degradation of the active ingredient and the need of a reduced shelf life after first opening. Therefore the topic "in-use stability testing of human medicinal products" was brought forward to the QWP of the CPMP^cby a member of the BlfA. Austria was appointed as rapporteur for the elaboration of the corresponding guideline.

Keywords:

instability of drug products after first opening, new CPMP guideline for in-use stability testing of human medicinal products

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Die Benzidinblau-Reaktion in der pharmazeutischen Analytik

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