The European Pharmacopoeia has recently published a uniform monograph for cannabis flowers that sets clear standards for the quality and content of active ingredients. This monograph will form the basis for the quality assurance of medicinal cannabis in Europe.
The new European Pharmacopoeia guidelines define clear parameters for the production and testing of cannabis flowers. This ensures that patients have access to safe and high-quality products.
Dr. Johannes Junemann, Head of Quality Control at Quality Services International GmbH, expressed his delight at this development: “The introduction of this uniform monograph is an important step for the standardization of medicinal cannabis production in Europe. It ensures that patients have access to safe and high-quality products.”
Quality Services International GmbH, the leading company in the field of medicinal cannabis quality control, has announced that it is working on the implementation of the new monograph with immediate effect. The implementation will be completed well in advance of its entry into force on 1 July 2024. Dr. Junemann emphasized the importance of this step: “Our experts are working closely with manufacturers to ensure that they meet the requirements of the new monograph and make the transition as simple as possible for all parties involved to ensure patient care.”
The new monograph contains detailed requirements for the quality, active ingredient content and purity of cannabis flowers. The significant changes compared to the cannabis flower monograph in the German Pharmacopoeia include:
• When testing for extraneous constituents, no seeds may be present in the flowers to ensure the purity of the product
• Increase in the loss on drying from a maximum of 10 to 12 percent to take better account of the natural fluctuations in the moisture content of the flowers
• Addition of limits for heavy metals to ensure that medicinal cannabis is free from harmful contaminants
• Significant changes in the content determination for the analysis of cannabinoids to enable a more comparable and reliable determination of the active ingredient concentration
For further information on the new monograph and its implementation at Quality Services International GmbH, please contact:
Dr. Johannes Junemann
Head of Quality Control
Quality Services International GmbH