WHO Technical Report Series, No. 981 - World Health Organization

4. Quality control – International Reference
Materials (International Chemical Reference
Substances and Infrared Reference Spectra)
4.1 Update on International Chemical Reference Substances
4.1.1 Overview
International Chemical Reference Substances (ICRS) are reference substances that
are used as primary standards in physical and chemical tests that are described
in The International Pharmacopoeia, and for establishing official secondary
standards. The standards are officially adopted by the Expert Committee.
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4.1.2 Report on activities of the host organization related to
International Chemical Reference Substances
In 2010 the European Directorate for the Quality of Medicines & HealthCare
(EDQM) of the Council of Europe took over responsibility for establishing,
preparing, storing and distributing WHO ICRS. The Expert Committee received
a report from EDQM regarding this work, as of 31 March 2012. EDQM reported
that initial challenges in taking over existing stock of ICRS from Apoteket, which
was a former WHO collaborating centre responsible for the distribution of the
ICRS, had now been overcome. A good and productive working relationship
between EDQM and the staff of The International Pharmacopoeia was reported.
In 2011, EDQM distributed a total of 876 ICRS, with 61% of the total
number of items being sold within the WHO European Region. Eight studies
to establish new ICRS were carried out, and five new ICRS were provisionally
adopted or proposed for adoption. One study was performed to establish a new
International Infrared Reference Spectrum (IIRS) for proguanyl hydrochloride.
Monitoring for continued fitness for purpose was carried out on 19 ICRS.
EDQM noted the importance of verifying the feasibility and availability
of the envisaged International Chemical Reference Substance as the monograph
is being established. Further, it was pointed out that information in terms of
chemical composition and structure of the impurities intended to become ICRS
should be systematically included in The International Pharmacopoeia.
The Expert Committee thanked EDQM for its work and took note of
the report.
The secretariat informed the Expert Committee that EDQM announced
in 2012 that it could not carry out any production of ICRS involving compounding
of different materials into one ICRS. In addition, EDQM stated that it was
not in a position to establish ICRS that are not mentioned in The International
Pharmacopoeia, although they may be mentioned in other WHO quality assurance
documents.