20/21 September 2022
Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.
The Ph. Eur. draft CBD Monograph defines that CBD is isolated from natural sources. For comparison: The USP draft monograph defines that CBD is obtained from Cannabis sativa.
In addition, there is a German CBD DAC (Deutscher Arzneimittel Codex) monograph available. The DAC/NRF is a national formulary used in German pharmacies. It also includes CBD preparations, Cannabis flower preparations (e.g. for inhalation use or for tea preparation), Dronabinol preparations etc. The pharmacist can prepare these dosage forms for patients on prescription ("Formula officinalis"). The DAC CBD monograph states that CBD is obtained from flowers and leaves of Cannabis sativa L. from controlled cultivation, by synthesis or fermentation.
The proposed limits for selected impurities are the following:
More information on the Ph. Eur. CBD draft monograph is available after registration to Pharmeuropa.