Linnea is proud to comply with the new CBD monograph issued by the European Pharmacopoeia. This monograph is applicable for medical prescriptions, pharmacy compounding, clinical trials, pharmaceutical development, and registrations.
The final draft was published in January 2024, and starting from July 2024, the rules and requirements detailed in the official text will be obligatory for all member states. Previous guidelines, such as the DAC monograph on CBD, will be superseded by a unified set of specifications.
These specifications include:
- Functionality-related characteristics: these are crucial for the quality of a medicinal product and the consistency of its manufacturing process.
- Definition: the monograph specifies the content (98.0% to 102.0%) and clarifies that CBD is isolated from the Cannabis sativa L. plant.
- Characters:
- Appearance
- Solubility
- Identification:
- Infrared absorption spectrophotometry
- Specific optical rotation
- Storage
- Labelling
- Impurities: impurities are specified, cataloged, and acceptance criteria are provided for each.
Linnea maintains an ongoing relationship with the EDQM (European Directorate for the Quality of Medicines & HealthCare) and has been instrumental in the drafting of the CBD monograph.
Learn more about our GMP Certified Cannabinoid APIs and visit www.linneacannabinoids.ch for more information.
Or reach out to us today at
email: sales@linnea.ch
phone: +41 91 850 50 55