In-Use Stability of Medicinal Products Produced According to Homoeopathic or Anthroposophic Principles

Rubrik: europharm

(Treffer aus pharmind, Nr. 03, Seite 395 (2012))

Biber A | Blaha J | Boekhoff A | Brandenbusch K | Burgert R | Willing E | Steinhoff B

In-Use Stability of Medicinal Products Produced According to Homoeopathic or Anthroposophic Principles / Biber et al. • In-Use Stability Testing · Biber A, Blaha J, Boekhoff A, Brandenbusch K, Burgert R, Willing E, Steinhoff B · Deutsche Homöopathie-Union GmbH & Co. KG¹, Karlsruhe und Weleda AG Heilmittelbetriebe², Schwäbisch Gmünd und WALA Heilmittel GmbH³, Bad Boll und Hevert-Arzneimittel GmbH & Co. KG⁴, Nussbaum und Biologische Heilmittel Heel GmbH⁵, Baden-Baden und Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH⁶, Bensheim und Bundesverband der Arzneimittel-Hersteller e.V. ⁷, Bonn (all Germany)
The European “Note for Guidance on In-Use Stability Testing of Human Medicinal Products” (CPMP/QWP/2934/99) [ 1 ] defines the purpose of in-use stability testing as “to establish – where applicable – a period of time during which a multidose product can be used whilst retaining quality within an accepted specification once the container is opened”. In general, by nature of their physical form and chemical composition, multidose containers may pose a risk to their content with regard to e. g. degradation and/or microbiological contamination due to repeated opening and closing [ 1 ]. As homoeopathic and anthroposophic medicinal products – like ...