The Joint Research Centre joined forces with the European Directorate for the Quality of Medicines and Healthcare (EDQM) to develop reference materials needed for the determination of elements in medicinal products. These reference materials will ensure that EU citizens have access to safe and reliable medicinal products.
EDQM recently announced that the individual elemental CRS (Chemical Reference Standard) solutions of lead, cadmium, mercury and arsenic are now available in the catalogue of the European Pharmacopoeia reference standards. These CRS will support the European Pharmacopoeia chapter on elemental impurities (2.4.20).
The new reference standards 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. The reference standards were developed in partnership by EDQM, JRC, the National Metrology Institute of Germany (PTB) and the German Federal Institute for Materials Research and Testing (BAM). JRC's expertise, in particular with the certification and its practical contributions to the processing of reference materials, were highly valued by EDQM.
For more information visit the EDQM website.
- Publication date
- 23 February 2018