Purpose and Use
The EDQM supplies chemical reference substances (CRS) 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.
Specific batches of candidate material are selected. These are characterised at the EDQM laboratory using a number of methods including those described in the European Pharmacopoeia and according to the principles of ‘ISO Guide 34:2009 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.
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, other medicine control laboratories and industry to get involved in the establishment of its reference standards.