Purpose and Use

The EDQM supplies chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia.


Establishment

Specific batches of candidate material are selected. These are characterised at the EDQM laboratory according to the principles described in Chapter 5.12. (Reference Standards) of the European Pharmacopoeia and ‘ISO 17034 General requirements for the competence of reference material producers'.

Candidate materials can 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 example, for identification, purity tests or assays according to the corresponding monograph of general chapter of the European Pharmacopoeia.

For reference standards established within the Biological Standardisation Programme (BSP), go to BSP Background & Mission.


Participate in Establishing the Reference Standards

The EDQM encourages OMCLs and other medicine control laboratories and donors of candidate materials to get involved in the establishment of its reference standards.

PURPOSES AND USES



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statement

Conflict Affiliation & conflict of interest statement

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is an independent organisation, free from any undue influence and confirms that it does not have privileged ties with any pharmaceutical company or provider of reference standards.

Having been recently informed that certain commercial providers of reference standards claim their key staff are former senior employees of the EDQM, we questioned the companies concerned and received no reply.

We therefore confirm that, to the best of our knowledge, these claims are unfounded.

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Videos

Reference Standards
These short videos present how the Reference Standards (RS) are manufactured at EDQM and distributed worldwide from EDQM.


The EDQM secondary building
Video and Media kit