WESSLING’s experts tests pharmaceutical cannabis

WESSLING tests pharmaceutical cannabis

Since the amendment of the German Narcotics Act in March 2017, doctors have been allowed to prescribe cannabis blossoms and extract. In future, medicinal products made from cannabis are intended to provide, in certain cases, relief for severely ill people. The law defines strict drug and anaesthetic regulations that must be met before these drugs are allowed to enter the market. WESSLING’s experts have the knowledge and technical equipment to test compliance with the specified quality standards.

Testing by GMP laboratory

In Germany the Federal Institute for Drugs and Medical Devices (BfArM) strictly monitors the import, cultivation, supply and quality of medicines. Currently, this mainly affects importers who import the plant from abroad to Germany under the supervision of the Federal Opium Office. Cannabis grown in Germany, however, is not expected to be available until 2019 at the earliest. In order for the medicinal products to be approved for the European market, a GMP laboratory must have tested the cannabis medicinal product using established methods. At this point, the WESSLING experts support importers of pharmaceutical cannabis with their expertise and carry out tests for the origin, content and purity of the drugs. For this purpose, WESSLING holds the required GMP certificate at the Münster location as well as the BTM approval for testing cannabis blossoms in accordance with the German Pharmacopoeia's (DAB) monograph.

Special challenges in quality determination

There are various different types of cannabis, whose active ingredients, such as Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), hold significant differences in content. The quality of the material is therefore assessed by the THC/CBD ratio. The quantitative determination of these substances is of great importance for quality control. WESSLING uses high performance liquid chromatography (HPLC) and suitable reference substances to determine the exact concentrations and constituents of the drug.

Our range of services in the field of quality control of cannabis drugs and hemp products:

  • Identity (macroscopic, microscopic and by means of DC according to EP 2.2.26) 
  • Contents
  • Purity
  • Drying loss 
  • Absence of THC

Your contact person for the topic of cannabis medicinal products: