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European Pharmacopeia standards

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gros logo EDQMThe European Directorate for the Quality of Medicines and Healthcare within the Council of Europe provides support for the work of the Commission, making possible the activities of expert groups whose aim is to set up processes and controls to ensure the safety and quality of our medicines.

The Ph. Eur. comprises nearly 3,000 texts covering all therapeutic areas, from monographs describing legally binding quality standards for substances used in the manufacture of medicinal products to the issue of impurities in medicinal products.

EDQM provides chemical reference substances (SCRs), biological reference preparations (PBRs), herbal reference standards (VRSs) and reference spectra for use in tests and assays carried out in accordance with the official methods prescribed in the European Pharmacopoeia.

divers flacons de standards EDQM

Specific batches of the candidate substance are selected. They are characterised in the EDQM laboratory, in accordance with the principles described in chapter 5.12. Reference standards of the European Pharmacopoeia and in the ISO 17034 standard "General requirements for the competence of producers of reference materials".
Candidate substances may also be the subject of international collaborative studies. Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis for identification, purity testing or dosing, for example, in accordance with the corresponding monograph or general chapter of the European Pharmacopoeia.

Nearly 4,000 standards are available.

 

Documentation




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