Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1

At the beginning of April, Issue 13.1 of the European Pharmacopoeia (Ph. Eur.) was published. It will become applicable as of 1 January 2027 in 39 European countries. Among other texts, it includes the revised general chapter 2.8.25 High-performance thin-layer chromatography of herbal products.

As already apparent from the draft, the scope of HPTLC has been expanded. The chapter now refers more generally to “herbal products” rather than “herbal drugs and herbal drug preparations”, thereby enabling the application of the HPTLC technique beyond herbal drugs and herbal drug preparations.

The commentary information published alongside Ph. Eur. 13.1 (Pharmeuropa “Useful information” – Comments concerning texts published in Issue 13.1) highlights, among others, the following key areas of revision/extension:

• Equipment: more detailed information on suitable equipment for HPTLC.
• Preparation of solutions: additional guidance, including on reference solutions.
• Preparation of the chromatographic system: alternative application techniques (e.g. successive application/“co-spotting”).
• Saturation of the chamber and development of the plate: more detailed descriptions of chamber saturation and plate development (including in unsaturated chambers).
• System suitability test: broader in scope (not limited to the separation of only two closely migrating substances). In addition, monographs may provide for the use of an HPTLC system suitability solution CRS as a reference solution for system suitability testing, to verify system performance across the R_F range.
• Visual evaluation: additional guidance on visual evaluation, e.g. for minimum marker content and limit tests for adulterants.
• Quantitative evaluation: newly included, explicitly extending the scope to quantitative HPTLC applications.

A complete overview of all new and revised texts in Issue 13.1 can be found here.