Tests in the New Ph. Eur. Monograph on Cannabis Flower
Existing national monographs have been used in the preparation of this new monograph, e. g. the monographs of Germany, Denmark, the Netherlands and Switzerland.
The Ph. Eur. monograph on Cannabis flower covers the herbal drug used as a raw material for the production of extracts, or prescribed as is, to be taken by patients by inhalation or oral administration (i.e. prescribed to patients as a medicinal product).
The European Directorate for the Quality of Medicines and HealthCare (EDQM) presented key points and background information in a webinar on 14 December 2023.
This feature summarises the necessary tests required by the monograph.
|
Tests Cannabis |
Maximum |
Comment/Background Information |
|---|---|---|
|
Total CBN: sum of |
1.0 % |
Contents of more than 1.0 % of CBN indicate significant degradation of the herbal drug. Liquid chromatography (UV detection) with an octadecylsilyl silica gel column is the method of choice. |
|
Foreign Matter |
2.0 % |
Seeds and leaves longer than 10 mm are considered foreign matter. |
|
Loss on Drying |
12.0 % |
It is necessary to perform this test at low temperature (40 °C) and under 'medium vacuum' to minimise evaporation of non-water volatiles (e.g. essential oil/terpenes). |
|
Arsenic |
0.2 ppm |
If the herbal drug is not used as a medicinal product, the same limits as in the general monograph Herbal Drugs (1433) apply. Otherwise, the listed limits derived from ICH Q3D for Class I elements based on the permissible daily inhalation exposure apply. |
|
Cadmium |
1.0 ppm |
|
|
Lead |
5.0 ppm |
|
|
Mercury |
0.1 ppm |
Figure 1 Test of Ph. Eur. Cannabis flower monograph
A specification for moulds is not included in the monograph but this is covered in the general chapter on foreign matter (2.8.2) – ‘other foreign elements‘. A risk assesment shall be carried out for the control of moulds. The sampling procedure and the expected appearance of the herbal drug are defined. Mould control is also covered by GACP (Good Agricultural and Collection Practice).
Other applicable tests according to the general monograph Herbal Drugs (1433) are:
|
Other tests from the |
Comment/Background Information |
|
Pesticides |
If cultivation takes place in a closed environment where contamination with pesticides is not possible, the manufacturer may justify not testing for pesticides by the design and agricultural method of production. This approach must be agreed with the competent authority. |
|
Aflatoxin B1 |
According to the general chapter Determination of aflatoxin B1 in herbal drugs (2.8.18) herbal drugs must not contain more than 2 µg/kg of aflatoxin B1. |
|
Microbial contamination |
If the herbal drug is used as a medicinal product, the limits in Ph. Eur. chapters 5.1.8 Microbiological quality of herbal medicinal products for oral use and |
Figure 2 Other test from the monograph Herbal Drugs (1433)
Test for other aflatoxins than aflatoxin B1 are not included in the monograph because Cannabis flower does not present a particularly high risk of being affected by fungal infections. Cannabis flos does not have a particularly high sugar content.
A test for total ash is not included in the monograph because mineral contamination of Cannabis flower is expected to be very low.
Sources
Ph. Eur. Monograph on Cannabis flower (3028)
EDQM-Webinar: The new Ph. Eur. Cannabis flower monograph (3028), Thu, Dec 14, 2023
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