EP cGMP CBD Isolate
REQUEST COA Vantage Hemp’s EP cGMP CBD Isolate is a high-purity active pharmaceutical ingredient (API), that meets the specifications of European Pharmacopoeia monograph 07/2024:3151 with 98%-102% CBD content and non-detectable Δ9-THC, residual solvents, pesticides, and heavy metals. (European Pharmacopoeia)

EP cGMP CBD Isolate (European Pharmacopoeia)

 

Vantage Hemp’s EP cGMP CBD Isolate meets the stringent European Pharmacopoeia (Ph. Eur.) analytical profile, making it an optimal candidate for formulations requiring precise dose standardization, such as orally administered CBD medications, novel drug delivery systems, and transdermal patches. The absence of THC ensures compliance in markets where THC detection in pharmaceutical or nutraceutical products is prohibited.

 

For drug developers seeking regulatory approval in the UK (MHRA) and the EU (EMA), this API provides a validated, pharmacopoeia-grade source of cannabidiol. Additionally, R&D teams preparing FDA Investigational New Drug (IND) submissions may find this isolate valuable for clinical trial applications. From a procurement standpoint, utilizing a Ph. Eur.-compliant API simplifies regulatory filings for EU-based pharmaceutical and nutraceutical products, enhancing global marketability and differentiation within a competitive cannabinoid supply chain.

Read About Our EP Compliant CBD Isolate

Key Characteristics of EP cGMP
CBD Isolate

 

    • 98%-102% Cannabidiol (CBD) purity
    • Conforms to the newly released European Pharmacopoeia monograph 07/2024:3151
    • Non-detectable levels of Δ9-THC, mycotoxins, residual solvents, heavy metals, and pesticides​
    • ISO/IEC 17025:2017 accredited laboratory testing

Regulatory and R&D Relevance

    • Meets the specifications for the European Pharmacopoeia monograph for CBD
    • Meets a key requirement for CEP application and Marketing Authorization in EU member states