Ph. Eur. Draft Monograph for CBD

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.

Definition of Source

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.

Impurities

The proposed limits for selected impurities are the following:

Cannabidibutol: max. 0.2 per cent;
Cannabidivarin: max. 0.15 per cent;
Cannabinol: max. 0.15 per cent;
Delta-9-THC (Dronabinol): max. 0.10 per cent (i.e., the same limit as proposed in the USP draft CBD monograph and provided in the current official DAC CBD monograph);
Any other (unspecified) impurity: for each impurity, max. 0.10 per cent (i.e., the same limit as proposed in the USP draft CBD monograph and provided in the current official DAC CBD monograph);
Total: max. 0.8 per cent (USP CBD draft monograph: max. 2.0 per cent; DAC CBD monograph: max. 0.5 per cent).