Cannabis Reference Standards DAB

Recommendation

5/6 October 2023

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In the Federal Gazette (Bundesanzeiger) of 23 May 2023, an announcement of the German Federal Institute for Drugs and Medical Devices (BfArM) of 15 May 2023 concerning the German Pharmacopoeia (Deutsches Arzneibuch, DAB) was published. The announcement lists the new and revised DAB texts and monographs adopted by the DAB Commission in October 2022.

Revised Cannabis Reagents

The 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. In a previous notice from the BfArM the Expert Committee for Pharmaceutical Biology recommended revised reagent descriptions for inclusion in the DAB.

The DAB 2023 now includes in chapter "N 4 Reagents" the following revised texts for Cannabis reagents:

• Cannabidiol RN
• Cannabidiolic Acid RN
• Cannabinol RN
• Delta-8-Tetrahydrocannabinol RN
• Delta-9-Tetrahydrocannabinol RN
• Delta-9-Tetrahydrocannabinolic Acid RN

The amended German Pharmacopoeia (DAB) is valid from 1 August 2023. The new version is entitled "Deutsches Arzneibuch 2023 (DAB 2023)" and can be obtained from the German publisher "Deutscher Apotheker Verlag".