New Ph. Eur. Cannabis Reagents
Recommendation
5/6 June 2024
All relevant GMP/GDP/GACP aspects for Medical Cannabis
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Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph (to be published in Ph. Eur. 11.5) new Ph. Eur. cannabis reagents are needed for quality control purposes (e.g. for the test on identity via Thin Layer Chromatography in the Cannabis Flower monograph). Hence, the description of the following four Cannabis reagents will also be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5:
- Cannabidiol (CBD)
- Cannabidiolic acid (CBDA)
- Delta-9-Tetrahydrocannabinol (THC)
- Delta-9-Tetrahydrocannabinol (THC) solution.
Moreover the Ph. Eur. Cannabis Flower Monograph requires the use of cannabis flower for system suitability HRS (herbal reference standard) and cannabidiol for cannabis CRS (chemical reference substance). However, neither of which is currently listed in the Ph. Eur. reference standards catalogue. An announcement will be made on the EDQM website when these reference standards become available.
More information is available in the overview on New reagents published in the European Pharmacopoeia published at the Pharmeuropa website.
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