The New Ph. Eur. Monographs Cannabis Flower and CBD are now Published

The European Pharmacopoeia (Ph. Eur.) Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph (already pre-published in October 2023) and the new Ph. Eur. monograph Cannabidiol (CBD). The new Ph. Eur. Cannabis flower monograph replaces the previous existing national monographs (NL, DK, D, and CH) as of 1 July 2024.

The new Cannabis Flower monograph covers:

• raw materialfor the production of extracts,
• medicinal productsthat can be prescribed as is (= herbal drug), to be taken by patients by inhalation or oral administration.

Additional requirements have been included in the limits for content, in the production section, and in the tests for foreign matter and heavy metals for cases in which the herbal drug is to be prescribed to patients as a medicinal product. The Loss on drying (LOD) limit has been set to max. 12.0 %.

The Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant.