Document Type
Oral Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
9-4-2025 8:30 AM
Description
The European Pharmacopoeia (Ph. Eur.) is an international regulatory document setting the standards for the quality control of medicinal products. It is elaborated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), a body of the Council of Europe, headquartered in Strasbourg, France. It is mandatory in 39 European countries and the European Union. The Ph. Eur. establishes quality specifications for active ingredients, excipients, dosage forms, and finished products. In relation to herbal medicinal products, the upcoming 12th Edition (effective January 2026) includes: 25 general methods in pharmacognosy, 6 general monographs, 2 information chapters, and 392 individual monographs covering herbal drugs, extracts, essential oils, vegetable fatty oils, exudates, starches, and more. Herbal-related monographs account for approximately 15% of all individual monographs of the Ph. Eur. Recent key developments in the Ph. Eur. for herbal medicinal products include: • A new general analytical method for determination of contaminant pyrrolizidine alkaloids. • A general chapter on HPTLC analysis of herbal products, introducing a more detailed description of the analytical procedures, a system suitability test, intensity markers to improve the description of acceptance criteria, chromatogram images for user guidance, and the implementation of quantitative capacities of HPTLC. • The publication of the monograph on cannabis flower (January 2024), defining three types based on cannabinoid contents and specifying differentiated requirements for two application-based types. • Transitioning from spectrophotometric to HPLC assay methods for hydroxyanthracene derivatives in herbal drugs and their standardized extracts. Together with the Ph. Eur. secretariat, more than 70 experts from academia, industry, and regulatory agencies across over 20 European and non-European countries collaborate on the elaboration and revision of monographs, including experimental work, to ensure the continuous advancement and updating of quality standards for herbal medicinal products. The Ph. Eur. laboratory is responsible for establishing and maintaining the chemical reference substances (CRS) and herbal reference substances (HRS) required for the application of monographs.
Recommended Citation
Canigueral, Salvador, "The contribution of the European Pharmacopoeia to the quality control of herbal medicinal products" (2025). Oxford ICSB. 33.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/33
Publication Date
April 2025
Accessibility Status
Searchable text
Included in
The contribution of the European Pharmacopoeia to the quality control of herbal medicinal products
Oxford Conference Center, Oxford MS
The European Pharmacopoeia (Ph. Eur.) is an international regulatory document setting the standards for the quality control of medicinal products. It is elaborated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), a body of the Council of Europe, headquartered in Strasbourg, France. It is mandatory in 39 European countries and the European Union. The Ph. Eur. establishes quality specifications for active ingredients, excipients, dosage forms, and finished products. In relation to herbal medicinal products, the upcoming 12th Edition (effective January 2026) includes: 25 general methods in pharmacognosy, 6 general monographs, 2 information chapters, and 392 individual monographs covering herbal drugs, extracts, essential oils, vegetable fatty oils, exudates, starches, and more. Herbal-related monographs account for approximately 15% of all individual monographs of the Ph. Eur. Recent key developments in the Ph. Eur. for herbal medicinal products include: • A new general analytical method for determination of contaminant pyrrolizidine alkaloids. • A general chapter on HPTLC analysis of herbal products, introducing a more detailed description of the analytical procedures, a system suitability test, intensity markers to improve the description of acceptance criteria, chromatogram images for user guidance, and the implementation of quantitative capacities of HPTLC. • The publication of the monograph on cannabis flower (January 2024), defining three types based on cannabinoid contents and specifying differentiated requirements for two application-based types. • Transitioning from spectrophotometric to HPLC assay methods for hydroxyanthracene derivatives in herbal drugs and their standardized extracts. Together with the Ph. Eur. secretariat, more than 70 experts from academia, industry, and regulatory agencies across over 20 European and non-European countries collaborate on the elaboration and revision of monographs, including experimental work, to ensure the continuous advancement and updating of quality standards for herbal medicinal products. The Ph. Eur. laboratory is responsible for establishing and maintaining the chemical reference substances (CRS) and herbal reference substances (HRS) required for the application of monographs.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/33