Ph. Eur. Reference Standards
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. The existence of official reference standards recognised throughout Europe enables national control agencies and manufacturers to avoid costly duplication of work on secondary standards, which could otherwise lead to disagreements among member states and to problems of mutual recognition.
Establishment
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.
Learn how to ‘Get Involved in the Establishment of CRS' or how to ‘Participate in a BSP Collaborative Study'.
Latest news
(08/10/12) New Reference Substances for the Assay of Allergen Preparations
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Events
9-10 July 2013: 8th Edition European Pharmacopoeia Training Session (Chemicals)
Strasbourg, France
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Products & Services
Search for availability, price, batch validity statements (BVS), leaflets, safety data sheets (SDS), a list of newly adopted reference standards and batch release dates using the Online Ph. Eur. Reference Standards Database.
To order: Products & Services: Ph. Eur. Reference Standards
The Terms of Supply and Instructions for Use are available in English and in French.
Access for existing clients
Free access
EDQM Council of Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
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