WHO International Chemical Reference Substances (ICRS) : Purposes & Use
About WHO ICRS
On 16 April 2010, the EDQM took over responsibility for the establishment, storage and distribution of WHO ICRS from Apoteket AB, the previous WHO Collaborating Centre for these substances.
ICRS are adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are intended primarily for use in physical and chemical tests and assays described in the specifications published in ‘The International Pharmacopoeia' for the quality control of pharmaceutical substances and preparations.
Note from the Secretariat of The International Pharmacopoeia – Intended use of ICRS
The International Pharmacopoeia constantly develops new monographs and revises existing ones to stay abreast of advances in analytical science and regulatory affairs. Along with these changes the intended use of already established ICRS often needs to be adjusted, for example, because an ICRS previously used for identification only shall newly also be employed in quantitative tests.
The user of The International Pharmacopoeia finds information on the actually established intended uses of an ICRS in the leaflet enclosed with the substance when distributed or accessible via the ICRS online database. The information found in current leaflets is applicable to all standards of the respective batch number.
ICRS Establishment Studies
The EDQM organises international collaborative studies to establish new standards when required, with the WHO's assistance.