New standardised Ph. Eur. monograph on cannabis flowers (3028): Ph. Eur. method already implemented in analysis

In October 2023, the European Pharmacopoeia published a standardised monograph for cannabis flowers (3028). This will apply from 1 July 2024, replacing the current national monographs (NL, DK, D and CH). The monograph will thus form the basis for the testing of medicinal cannabis in Europe.

The new monograph refers to the herbal drug, which is defined as the dried, whole, or crushed, fully developed female inflorescences of Cannabis sativa L. It is to be read in conjunction with the general monograph “Herbal Drugs” (1433).

Significant changes compared to the monograph Cannabis flowers in the German Pharmacopoeia are the new limit values for the content and testing for foreign components and heavy metals:

  • The drying loss limit value has been increased to a maximum of 12%.
  • The limit values for arsenic, cadmium and lead have been supplemented: due to the inhalation application, they are significantly lower than those in the general Ph. Eur. monograph (based on ICH Q3D).
  • Testing for foreign components is much more extensive: in future, no seeds, insects, mould or other components may be present in the flowers.
  • Containers must be hermetically sealed: a leak test of the packaging is required.
  • Changes in the determination of the cannabinoid content will lead to a better comparability of the active substance concentrations.

For testing for other impurities, such as aflatoxins, pesticides and microbiological quality, the European Pharmacopoeia continues to refer to the general Ph. Eur. Monograph on herbal drugs.

For many years WESSLING has been assisting companies wishing to grow cannabis for pharmaceutical purposes in Germany or import flowers and oils. At our GMP-certified laboratory location in Münster, over 70 experienced employees carry out quality controls on cannabis by testing cannabis products for identity, content, and purity. Therefore, we have already implemented the new Ph. Eur. method and can conduct the tests on request.

Find out more about our range of services in the field of consulting and analysis of pharmaceutical cannabis here.

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© WESSLING - Maik Siebelmann
„Take a relaxed approach to this alteration and have your pharmaceutical cannabis analysed by us according to the Ph. Eur. monograph method.“