New Ph. Eur. Chapter on Estragole – Ensure Compliance with our phyproof® Standard

PhytoLab ensures that your compliance needs are met and is offering you an outstanding portfolio of highly purified phyproof^Ò reference standards for your analysis according to the European Pharmacopoeia (Ph. Eur.).¹ Recently, a new chapter for the quantitative determination of Estragole in herbal drugs and herbal drug preparations has been drafted – Chapter 2.8.27. Determination of Estragole.²

Estragole is a phenylpropanoid naturally occurring in various essential oils (e.g. anise, fennel, star anise). It is under scrutiny due to its suspected genotoxic and carcinogenic effects. The HMPC has emphasized the need to minimise exposure. The proposed gas chromatography-based method has been validated for specific matrices (anise, anise oil, star anise, star anise oil, sweet fennel, bitter fennel, cut bitter fennel, bitter fennel oil and bitter fennel herb oil). The suitability to other herbal substances must be demonstrated or another validated method must be used. The deadline for comments ends on September 30, 2025.

Be analytically prepared – with our Certified Estragole Reference Standard (CAS No. 140-67-0)

We offer high-purity, fully documented and certified Estragole that meets the demands of both regulatory compliance and analytical performance: Equip your lab with reliable standards for method validation & routine analysis – and contact us @ref-substances@phytolab.de today to learn more about how phyproof® Estragole can support your analytical needs!

Do you need an analysis of Estragole in your products? We will be happy to provide you with our services. For further information, please contact: martin.mueller@phytolab.de

Literature

[1] European Pharmacopoeia (Ph. Eur.), General Chapters and Monographs on Herbal Drugs and Herbal Drug Preparations. Council of Europe. https://www.edqm.eu/en/european-pharmacopoeia
[2] European Directorate for the Quality of Medicines & HealthCare (EDQM), Pharmeuropa 37.3., Chapter 2.8.27. Determination of estragole (20827), PA/PH/Exp. 13A/T (25) 23 ANP https://pharmeuropa.edqm.eu/home