Saturday, June 20, 2009

Quality control — reference materials

3.1 International Chemical Reference Substances
The 1997 and 1998 reports of the WHO Collaborating Centre for
Chemical Reference Substances were presented to the Committee.
Nine new International Chemical Reference Substances (ICRS)1
were adopted by the Committee according to the procedure described
in its thirty-second report (10). The recommendation to withdraw
the reference substance for tubocurarine hydrochloride was
endorsed since it is no longer required. The total collection now
comprises 205 chemical reference substances and 12 melting-point
reference substances (Annex 1).
The Committee adopted the reports and expressed its appreciation to
the WHO Collaborating Centre for Chemical Reference Substances
for its work, and to the National Corporation of Swedish Pharmacies
for its continued financial support to the WHO programme on ICRS.
3.2 International Infrared Reference Spectra
A total of 69 International Infrared Reference Spectra (IIRS) are
currently available from the WHO Collaborating Centre for Chemical
Reference Substances, Kungens Kurva, Sweden (Annex 2). The
Committee acknowledged the contribution of the WHO Collaborating
Centre for International Infrared Reference Spectra, Zurich,
1 Captopril, captopril disulfide, ciprofloxacin hydrochloride, cisplatin, kanamycin
monosulfate, piperazine adipate, piperazine citrate, sodium amidotrizoate and
streptomycin sulfate.
Switzerland, which prepares the spectra. It was agreed that in future
the infrared reference spectra would be recorded on a Fourier transform
infrared spectroscopy instrument and that they should be published
in reduced size, either in The international pharmacopoeia or as
a separate publication.
3.3 Biological reference materials
The Committee noted that the WHO Expert Committee on Biological
Standardization was carrying out a review of biological reference
materials. Any such materials proposed for discontinuation as a
biological reference material would be assessed by the WHO Collaborating
Centre for Chemical Reference Substances for its potential
suitability for use as

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