Vantage Hemp’s EP Compliant CBD Isolate Meets the Specifications of the European Pharmacopoeia CBD Monograph
The European Pharmacopoeia (Ph. Eur.) has recently published new monographs, including one specifically for Cannabidiol (CBD). This monograph, published in Supplement 11.5 of the Ph. Eur., became effective in July 2024. It establishes stringent quality standards for CBD derived from Cannabis sativa L., which is of particular significance for the medicinal and therapeutic cannabis sector across Europe.
The CBD monograph sets guidelines for the production, identification, purity, and safety of isolated CBD. It aims to harmonize quality control processes across European member states by defining standards such as impurity limits, characterization methods, and testing procedures. This includes requirements for organic impurities and potential contaminants, ensuring that CBD products are safe for medicinal use.
Alongside the Cannabis Flower monograph (3028), these developments provide a comprehensive framework for the quality management of cannabis-based products. Both monographs will help manufacturers ensure consistent, high-quality outputs while complying with legal standards. This is a significant step toward improving the quality, safety, and efficacy of cannabis products in Europe.
Vantage Hemp’s EP Compliant CBD Isolate
Vantage Hemp’s Certificate of Analysis (CoA) for EP Compliant CBD Isolate (Batch: VH240043) demonstrates full compliance with the newly adopted European Pharmacopoeia (Ph. Eur.) monograph 07/2024:3151 for Cannabidiol (CBD).
Here’s an analysis based on the key specifications and test results:
Cannabidiol Assay (Purity)
Specification: The Ph. Eur. monograph requires CBD purity between 98.0% and 102.0%.
Result: The assay determined the CBD content as 99.50% (on an anhydrous basis), well within the required range, ensuring high purity.
Identification Tests:
The CoA confirms CBD identification through multiple methods, including Specific Optical Rotation, Infrared Absorption, Retention Time Match, and UV Spectra, all conforming to the Ph. Eur. standard, thus verifying the CBD’s identity.
Impurities
Related Compounds: The monograph sets strict limits on related cannabinoids and other potential impurities. Vantage Hemp’s product meets all the requirements, with significant impurities such as Δ9-THC and Cannabinol (CBN) being not detected (ND), and all other impurities falling well below the acceptable limits.
Total Impurities were reported at 0.39%, far below the 1.5% maximum allowed by the Ph. Eur., ensuring a clean and high-quality isolate.
Loss on Drying
Specification: The CBD isolate must have a loss on drying value below 0.5%.
Result: Vantage Hemp’s isolate shows a very low loss on drying value of 0.1%, demonstrating excellent moisture control.
Residual Solvents
Tested per Ph. Eur. 2.4.24, all residual solvents, including methanol, n-butane, and pentane, were either not detected or below the quantifiable limit, indicating a clean production process that meets the stringent European standards.
Elemental Impurities
Vantage Hemp’s isolate was tested for heavy metals in compliance with Ph. Eur. 2.4.27. No detectable levels of arsenic, cadmium, lead, or mercury were found, ensuring the product’s safety for medicinal use.
Microbial and Mycotoxin Testing
Microbial contamination was tested per Ph. Eur. 2.6.12/2.6.13, with results showing no contamination from pathogens like Salmonella, E. coli, or Staphylococcus aureus. Mycotoxin levels, such as aflatoxins and ochratoxin A, were below detection limits, ensuring compliance with Ph. Eur. 2.8.18/2.8.22.
Pesticide Residue Testing
Pesticide residues were tested against the specifications in Ph. Eur. 2.8.13, with none detected. This guarantees that the CBD isolate is free from harmful agricultural contaminants.
Pharmaceutical Grade and EP Compliant CBD
Vantage Hemp’s EP Compliant CBD Isolate (Batch VH240043) is fully compliant with the European Pharmacopoeia monograph for CBD (07/2024:3151). The product meets all critical specifications for purity, identity, impurities, and safety, ensuring it is suitable for medicinal applications in the EU market. This high level of compliance reflects Vantage Hemp’s commitment to producing pharmaceutical-grade CBD that aligns with international standards.
If you are searching for a reliable CBD supplier and manufacturing partner for European markets, contact Vantage Hemp Sales today.
