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Ph.Eur. – European Pharmacopoeia (EP)

  • EP – European Pharmacopoeia (Ph. Eur.)
  • The European Directorate for the Quality of Medicines (European Directorate for the Quality of Medicines & HealthCare – EDQM) is an European authority located in Strasbourg and is part of the Council of Europe
  • The EDQM has the task to network and to control the official medicines investigation authorities of the European States
    (Official Medicines Control Laboratories – OMCL), to co-ordinate the European Pharmacopoeia Commission and to ensure the quality of medicines
  • The EDQM issues the European Pharmacopoeia as a binding set of regulations
  • The European Pharmacopoeia defines the quality requirements for the testing of pharmaceutical products. It contains monographs with quality standards to be met, texts to classes of products, formulations, analytical methods and reagents
  • The EDQM issues qualification certificates to ensure that active substances from various sources (manufacturers) comply with the monographs of the European Pharmacopoeia
  • The EDQM provides Chemical Reference Substances (CRS) and Biological Reference Preparations (BRP) as well as reference spectra for the tests and assays in accordance to the European Pharmacopoeia

EDQM Reference Standards to be purchased at Eurofins | PHAST

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