International Chemical Reference Substances are established upon the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in The International Pharmacopoeia or proposed in draft monographs. The International Chemical Reference Substances are mainly intended to be used as primary standards to calibrate secondary standards.

Directions for use and required analytical data for the intended use in the relevant specifications of The International Pharmacopoeia are given in the certificates enclosed with the substances when distributed.

International Chemical Reference Substances may also be used in tests and assays not described in The International Pharmacopoeia. However, the responsibility for assessing the suitability of the substances then rests with the user or with the pharmacopoeia commission or other authority that has prescribed this use.

It is generally recommended that the substances should be stored protected from light and moisture and preferably at a temperature of about +5°C. When special storage conditions are required, this is stated on the label or in the certificate. It is recommended to the user to purchase only sufficient amount for immediate use.

The stability of the International Chemical Reference Substances kept at the WHO collaborating host organization is monitored by regular re-examination and any material that has deteriorated is replaced by new batches when necessary. Lists giving control numbers for the current batches are issued in the annual reports from the host organization and new lists may also be obtained on request.

Ordering information

Orders for the International Chemical Reference Substances should be sent to:

European Directorate for the Quality of Medicines & HealthCare
7 allée Kastner
CS 30026
F-67081 Strasbourg
France
Fax: +33 (0)3 88 41 27 71 - for the attention of EDQM Sales Section
E-mail: orders@edqm.eu
web site: http://www.edqm.eu/en/WHO-International-Chemical-Reference-Substances-ICRS-1393.html

The current price for the International Chemical Reference Substances (ICRS) is 70 Euros per package. Extra charges will be added for the delivery of the reference substances. For details see the above mentioned web site.