Ph. Eur. Cannabis Monograph Proposed for Comment

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa 34.4 with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs (e.g. the German DAB monograph). In addition, the Ph. Eur. is also working on monographs for Cannabis extracts.

Definition

Dried, whole or fragmented, fully developed shoot apices of female cultivars of Cannabis sativa L.

Production

If the herbal drug is to be prescribed to patients, the shoot apices are cut directly at the base, with minimal stalk remaining.

Cannabinoids

The proposed monograph includes specific requirements for the following 3 chemotypes (similar to the recently proposed USP HMC monograph):

  • High THC type (10.0 % - 30.0 % total THC / max. 1.0 %  total CBD) 
  • THC/CBD type (3.0 % - 15.0 % total THC / CBD)
  • High CBD type (5.0 % - 20.0 % total CBD / max. 1.0 % total THC)

Content Limits:

  • Total Cannabinol (CBN): max. 1.0%.
  • 90% - 110% of the labeled total amount of Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) ("total" means with the corresponding acids).

In contrast to the proposed USP HMC monograph requirements for terpenes are not included.

Other Tests

The proposed limits for heavy metals are significantly lower compared to those provided in the general Ph. Eur. monograph Herbal Drugs (presumably due to the potential inhalation use). However, they are aligned with the limits proposed in the USP HMC monograph:

Arsenic: max. 0.2 ppm
Cadmium: max. 0.3 ppm
Lead: max. 0.5 ppm
Mercury: max. 0.1 ppm

Foreign matter: Max. 2 %. If the herbal drug is to be prescribed to patients (i.e. if the herbal drug is not only to be used as starting material for the preparation of extracts etc.), it does not contain any seeds and the whole herbal drug does not contain any leaves more than 1.0 cm in length.

Loss on drying: Max. 10.0 %.

However, regarding mycotoxins, pesticides and microbiological quality it is still required to refer to the general Ph. Eur. monograph Herbal Drugs.

Storage & Labelling

Storage: In an airtight container. The label states the contents of total THC and total CBD (%). In addition, the label states if the herbal drug is to be prescribed to patients (Dispensing Drug).

More information is available in Pharmeuropa Online.

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