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

Quality control – International Reference Materials
After testing of candidate material, the custodian centre for ICRS
will submit analytical case-reports to a newly established Expert
Committee subgroup on ICRS, which should consist of three
experts and a representative of the secretariat. The subgroup will
decide on the suitability of the reference substance and adopt the
ICRS on behalf of the Expert Committee. During the following
meeting of the Expert Committee, the subgroup will report on the
newly released ICRS.
A revised procedure appears as Annex 1 to this report.
The Expert Committee approved the nomination of Professor Dekker,
Professor Hoogmartens and Professor Jin as members of the subgroup on ICRS.
Each subgroup member should nominate one other expert from their respective
collaborating centres as a back-up.
4.1.6 Policy on naming International Chemical Reference
Substances in The International Pharmacopoeia
Following a discussion on the policy for naming ICRS in The International
Pharmacopoeia, the Expert Committee adopted a proposal to use the following
nomenclature for reference standards in new monographs:
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for standards on active pharmaceutical ingredients: [INNM name]
RS;
for standards on impurities: [INN name of respective API] impurity
[A, B, C or …] RS;
for standards or mixture of standards used for system suitability
tests or peak identification, as intended: [INN name] for system
suitability RS;
[INN name] for peak identification RS;
for substances used to calibrate melting-point instruments: [INN
name] Melting Point RS.
The Expert Committee adopted the new proposal as a step towards
a systematic way of expressing the names for ICRS in future and recognized
that the certificate of analysis accompanying the ICRS would include further
information on the precise nature of the substance.
4.1.7 Proposal to reduce analytical testing of high-purity candidate material
The Expert Committee reviewed a proposal to reduce collaborative testing of
high-purity candidate material for ICRS used for assay and established using the
mass-balance approach. Assays of ICRS established by mass balance are usually
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