The
EDQM has updated the leaflets of its reference standards for elemental
impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and
arsenic solution CRS) with further information to facilitate their use and make
traceability transparent. The mass fractions of the assigned element are
traceable to the SI units (mole and kilogram) through an uninterrupted chain,
similar to certified reference materials established by a national metrological
institute.
More
detailed information on the assigned value and the associated expanded
uncertainty is now included in the leaflets accompanying the reference
standards. In addition, the solvent composition is explicitly stated, as well
as the density of the solution. The specific primary materials used to achieve
the link to the SI units are also indicated.
Elemental
impurities naturally occurring in the environment are amongst the greatest
potential sources of contamination. Public health standards, such as the ICH
Q3D Guideline for Elemental Impurities, require careful risk assessments of
sources for elemental impurities. The changes are part of the EDQM’s efforts to
provide efficient support to users of its pharmaceutical reference standards.
These reference standards also underpin the European Pharmacopoeia (Ph. Eur.)
chapter describing the determination of elemental impurities (2.4.20.).

Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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