On 1 June 2020, the long-awaited monograph “Cannabis exractum normatum” in the German Pharmacopoeia (DAB) came into force. This monograph provides the basis for a variety of THC and/or CBD cannabis extracts and allows the use of different carrier oils.
The monograph “C-054 Adjusted, refined cannabis oil resin” in the German Drug Codex (DAC), which was previously used for cannabis extracts and which exclusively required 5 % THC extracts in MCT oil, will now be removed from the DAC after a transitional period.
DSI-pharm (QSI GmbH), which was involved in the preparation of the new monograph, implemented the analysis of cannabis extract according to the then valid DAC monograph already more than a year ago.
Within the framework of a change control procedure, the coordinated changeover to the requirements of the new DAB monograph has now taken place after successful verification of the in-house method.
From now on, the analysis of cannabis extracts will therefore be performed exclusively according to the DAB monograph “Cannabis exractum normatum “.
The method for determining the content validated by DSI-pharm allows an optimized chromatographic separation of the cannabinoids as well as the quantification of THC-A and CBD-A which exceeds the monograph. This allows a control of the complete decarboxylation of the cannabinoid acids during the production of the extract.
In June DSI-pharm (QSI GmbH) also received the approval to conduct stability studies according to ICH guidelines.
Do you have any questions about the analysis of cannabis extracts according to DAB monograph, or would you like to take advantage of our services? We are pleased to provide you with an offer for stability studies for your cannabis extracts and also cannabis flowers! Please feel free to contact us!
Tel: +49 (0)421 / 59 66 070
Bremen, 01.07.2020Source: https://www.dsi-pharm.de/en/analysis-of-cannabis-extracts/