The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users of the European Pharmacopoeia (Ph. Eur.) to understand the principles behind the drafting and revision of herbal monographs.
This 2nd edition of the Guide, as approved by the Ph. Eur. Commission at its 175th session, has been completely overhauled and updated to reflect the latest versions of the relevant monographs and to take account of new Ph. Eur. texts published since the first edition was issued in 2005. For example, the sections on ‘Assay’ and ‘Herbal drug preparations’ have been substantially revised and expanded and the guide also includes new and useful information such as an example schematic drawing of the characteristic microscopic features of a powdered herbal drug and a section on identification by HPTLC (in accordance with general chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations). A new section referring to the recently implemented general chapter 2.8.26. Contaminant pyrrolizidine alkaloids – compounds found naturally in many common weeds that may adulterate herbal drugs – has also been added.
The Guide, together with other Ph. Eur. technical guides, is available on a dedicated page of the EDQM website.