|Stability Testing of Herbal Medicinal Products |
René Roth-Ehrang1, Sven Asche2, Michael Hubbert3, Sven Oliver Kruse4, Andrea Lutz-Röder5, Frank Poetsch6,
The European guideline on “Stability Testing of Existing Active Substances and Related Finished Products” provides guidance for stability testing and covers also herbal medicinal products. Based on these requirements and a draft Reflection Paper of the Committee on Herbal Medicinal Products (HMPC) published in January 2009, the following contribution intends to elucidate the regulatory requirements for stability testing of herbal medicinal products and to present proposals for appropriate approaches based on practical experiences of manufacturers.
pharmind 2010, Nr. 7, Seite 1166