Medicinal Cannabis
Tentamus Pharma & Med is permitted to perform narcotic drug analyses of medical cannabis.
The use of medicinal cannabis in Germany is subject to the Narcotic Drugs Act (BtMG) and is therefore tightly regulated. Tentamus Pharma & Med holds the necessary narcotic drugs licence from the German Federal Institute for Drugs and Medical Devices (BfArM) and is permitted to perform narcotic drug analyses of medical cannabis.
We conduct pharmacopoeial tests on herbal drugs to determine active substance content and purity and to detect impurities of any kind: our wide range of analysis methods includes detecting foreign matter, establishing the presence of pesticides and heavy metals and carrying out microbiological assessments of bacterial load.
In particular, terpene screening allows us to determine whether pyrrolizidine alkaloids are present in medicinal cannabis.
Narcotic drug analysis of medicinal cannabis
Batch release of your cannabis-based pharmaceuticals
We hold a manufacturing licence in accordance with Section 13 of the German Drugs Act (AMG), which enables our Qualified Persons to monitor pharmaceuticals testing and release products.
Analysis according to German Pharmacopoeia (DAB) “cannabis flos” monograph:
- Identity – macroscopic, microscopic, thin-layer chromatography (2.2.27)
- Purity – foreign matter (2.8.2), loss on drying (2.2.32), cannabinol (HPLC)
- Content determination (HPLC) – (Δ9-tetrahydrocannabinol, Δ9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid)
Analysis according to Ph.Eur. “herbal drugs” monograph:
- Pesticides (2.8.13)
- Heavy metals Cd, Pb, Hg, if necessary As (2.4.27)
- Aflatoxins B1, B2, G1 and G2 (2.8.18)
- Ochratoxin A (2.8.22)
- Microbiological quality (5.1.8 B)
- TAMC, TYMC, bile-tolerant gram-negative bacteria, coli bacteria, Salmonellae
Other testing procedures for cannabis-based pharmaceuticals:
- Terpene-Screening
- Detection of pyrrolizidine alkaloids