German Pharmacopoeia Drafts for Cannabis Reference Substances

Recommendation

5/6 June 2024

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All relevant GMP/GDP/GACP aspects for Medical Cannabis

The German Pharmacopoeia (Deutsches Arzneibuch, DAB) currently contains the two monographs Cannabis Flower and Cannabis Extract. Reference substances, such as cannabinol (CBN) and cannabidiol (CBD), are required for assay and purity tests, as well as for identity tests (TLC), specified therein. A notice from the Federal Institute for Drugs and Medical Devices (Bundesinstituts für Arzneimittel und Medizinprodukte, BfArM) dated from 9 February 2022 has now appeared in the Federal Gazette (Bundesanzeiger) of 17 February 2022 with a communication on the German Pharmacopoeia. The Expert Committee for Pharmaceutical Biology has recommended the following drafts for revised reagent descriptions for inclusion in the DAB:

• Cannabinol RN
• Cannabidiol RN
• Cannabidiolsäure RN
• Delta-8-Tetrahydrocannabinol RN
• Delta-9-Tetrahydrocannabinol RN
• Delta-9-Tetrahydrocannabinol-Säure RN

The revision concerns the change that 13C-NMR data can be used alternatively (or in addition to 1H-NMR data) for identification. Previously, substances must comply with 1H-NMR and 13C-NMR tests.

Ph. Eur. and USP

In the European Pharmacopoeia (Ph. Eur.), there are currently no Ph. Eur. reference substances for cannabis analysis provided (the Ph. Eur. cannabis monographs are currently under development). The USP has monographs for dronabinol and CBD (draft), among others, and already offers some reference substances (see USP's "Cannabis for medical use" website):

• Delta-9-Tetrahydrocannabinol  
• Exo-Tetrahydrocannabinol 
• Cannabinoid Acids Mixture 
• Cannabinoids Mixture 
• Cannabidiol Solution  
• Cannabidiol 

Delta-8-tetrahydrocannabinol (Δ-8-THC) is described in the USP under "Reagents" ("Use a suitable grade, which may be a solid material or a solution in methanol"). Several supply sources for "suitable grade" Δ-8-THC are also listed there.

Comments on the DAB drafts should be sent to the office of the Pharmacopoeia Commissions at BfArM by 14 April 2022 at the latest.