International Chemical Reference Substances (ICRS)
The International Chemical Reference Substances (ICRS) required to support the monograph specifications in The International Pharmacopoeia are established according to the General guidelines for the establishment, maintenance and distribution of chemical reference substances, by the WHO custodian organization for ICRS, the European Directorate for the Quality of Medicines & HealthCare (EDQM) , located in the Council of Europe, Strasbourg, France, since 2010.
This section provides information about ICRS and a link to online search.
About WHO ICRS
An online ICRS database has been established by EDQM. You can search for the availability and price by using substance name or Catalogue Code or CAS Registry Number.
Access to ICRS database and purchase of ICRS online at EDQM
ICRS are used by laboratories as primary standards in physical and chemical tests and assays described in The International Pharmacopoeia; or to calibrate secondary standards according to the General guidelines for the establishment, maintenance and distribution of chemical reference substance.
WHO/Council of Europe (EDQM) collaboration
In April 2010 WHO and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, announced collaboration on ICRS. WHO’s collection of ICRS is now maintained by the Council of Europe’s European Directorate for Quality of Medicines and HealthCare (EDQM) .
EDQM took over responsibility for the preparation, establishment, storage and distribution of WHO ICRS from Apoteket AB, which was previously the WHO Collaborating Centre for Chemical Reference Substances. EDQM organizes international collaborative studies to establish new standards. This partnership allows WHO to be supported by the technical expertise and experience of EDQM in establishing primary reference standards.
ICRS establishment, maintenance, distribution and release procedures
ICRS are adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations following a procedure aligned with the WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances. Lists of these substances are regularly updated. In order to expedite the establishment of new reference substances and enable WHO to react faster to the urgent demand for ICRS, the Expert Committee adopted a new ICRS release procedure at 2010 meeting for adoption of ICRS to accelerate their availability and release between Expert Committee meetings.