Regulatory‑ready testing aligned with the European Pharmacopoeia (EP)

Our laboratories apply EP‑aligned methodologies using validated microscopic and chromatographic techniques to generate high‑quality, regulator‑accepted data.

EP cannabis monograph methodology overview

Testing is performed in alignment with the European Pharmacopoeia cannabis flower and extract monographs, supporting medicinal cannabis quality control and regulatory compliance.

Identity testing

  • Macroscopic and microscopic examination to confirm botanical identity
  • Thin Layer Chromatography (TLC) for qualitative confirmation of cannabinoid profiles
  • Chromatographic techniques in accordance with EP identification requirements

Cannabinoid assays – Ph. Eur. 2.2.29

  • Liquid Chromatography (LC)–based quantitative determination of cannabinoids
  • High‑precision assays supporting EP compositional and content specifications

Safety and purity testing

  • Heavy metals analysis for arsenic, cadmium, lead, and mercury
  • Moisture content determination to support product stability and safety compliance
  • Foreign matter – Ph. Eur. 2.8.2
  • Microbiology Testing (including total aerobic plate count, total yeast and moulds, bile tolerant gram-negative bacteria, E. coli, salmonella, staphylococcus aureus, pseudomonas aeruginosa in accordance to EP Pharmacopeia methods)

All testing is conducted using validated methods consistent with EP expectations for pharmaceutical‑grade medicinal cannabis. 

Why EP monograph compliance matters

  • Harmonised European standard: One unified framework accepted across EP member states
  • Medicinal market access: Required for cannabis products supplied to EU medical channels
  • Pharmaceutical‑grade quality: Aligns cannabis testing with established drug‑product expectations
  • Regulatory confidence: Generates documentation suitable for submissions to European authorities

By meeting EP monograph requirements, producers can reduce regulatory friction and facilitate smoother cross‑border distribution within Europe. 

Your competence centre for EP cannabis monograph testing 

As part of the global Eurofins scientific network, Eurofins Experchem supports licensed cannabis producers seeking entry into European medical cannabis markets through robust, pharmacopoeial‑grade analytical testing. The European Pharmacopoeia (EP) cannabis monograph establishes a harmonised quality standard across 39 European countries, defining strict requirements for identity, purity, safety, and cannabinoid composition. 
 
With extensive experience in international cannabis compliance and pharmaceutical testing standards, Eurofins Experchem helps streamline regulatory submissions and supports confident market access across Europe. 

Get in touch

Would you like to learn more about our EP cannabis monograph testing or require tailored support for international market access? Contact our experts today to discuss your testing needs.

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