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EDQM Reference Standards: Purpose and Use
The EDQM can supply chemical reference substances and biological reference preparations as well as reference spectra for the tests and assays to be carried out in the accordance with the official methods of the European Pharmacopoeia. For more information, go to our European Pharmacopoeia reference standards database (under the Databases section).
The EDQM Guarantees Quality and Reliability
The batches are selected and checked at the EDQM laboratory using the methods described in the monographs and are suitable for the uses prescribed in the European Pharmacopoeia. These substances, preparations and spectra can be ordered from the EDQM.
How are Reference Standards elaborated?
Reference Standards are specially selected and verified batches certified by the European Pharmacopoeia Commission. Depending to their purpose (e.g. identification test, purity test, assays), they can be the subject of international collaborative studies. They are established and distributed according to the ISO Guide 34 general principles of and used in pharmaceutical analysis as standards for identification tests, tests for related substances, assays and also for calibration of instruments.
EDQM BRP: Purpose and Use
The existence of Reference Standards recognised throughout Europe will enable national control agencies and manufacturers to avoid costly duplications of work on secondary standards, which could otherwise lead to disagreements and problems of mutual recognition.
To this end, the Council of Europe, represented by the EDQM, and the Commission of the European Communities are now working on an extensive standardisation programme to set up collaborative studies to prepare European working standards. More information.
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