The European Directorate for the Quality of Medicines and HealthCare (EDQM) announces the availability of four new elemental impurity chemical reference standards (CRS) in its European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS. These elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for pharmaceutical use; the new reference standards underpin the European Pharmacopoeia (Ph.Eur.) chapter describing the determination of elemental impurities (2.4.20).
Element contents featured in these reference standards – which were developed in partnership by EDQM, the Joint Research Centre (JRC) of the EU Commission, the National Metrology Institute of Germany, Physikalisch-Technische Bundesanstalt (PTB), and the German Federal Institute for Materials Research and Testing (BAM) - are traceable to the SI (International System of units of measurements) and enable metrologically sound determination of lead, cadmium, mercury and arsenic as elemental impurities in medicinal products and substances for pharmaceutical use.
With the introduction of these reference standards, the EDQM is providing a tool that can support pharmaceutical manufacturers in their implementation of relevant public health standards, such as the ICH Q3D on Elemental Impurities, the quality guideline for the control of impurities in medicinal products.
EDQM training and webinars: register and obtain free access to the "Elemental Impurities Webinar" covering the implementation of the ICH Q3D in the context of PhEur texts & CEP applications.