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