Lead solution CRS, Cadmium solution CRS, Mercury solution CRS, Arsenic solution CRS, Nickel solution CRS, Palladium solution CRS and, most recently, Platinum solution CRS are now available in the EDQM RS portfolio.
For medicinal products, elemental impurities must be evaluated during risk assessment, taking into account all potential sources of contamination and routes of administration. They are grouped into three classes based on toxicity and likelihood of occurrence. The EDQM now provides reference standards for elemental impurities that present a high risk, including the Class 1 elements Cd, Pb, As and Hg, the Class 2A element Ni and the Class 2B elements Pd and Pt.
These seven reference standards are referred to in European Pharmacopoeia chapter 2.4.20. Determination of elemental impurities and are supplied with a detailed information leaflet which includes the exact mass fraction and the associated expanded uncertainty.
With the introduction of these reference standards, the EDQM provides SI-traceable primary reference materials that support pharmaceutical manufacturers in implementing relevant public health standards, such as the ICH Q3D Guideline for Elemental Impurities.
How to order or request a quotation
Orders or quotation requests can be submitted to the EDQM:
- using the WebStore.
- by e-mail to email@example.com. Please ensure that your order is on your company letterhead and states both the catalogue code and substance name, and is attached to your e-mail.
Please submit each order or request only once, either via the WebStore or by e-mail.
For more detailed instructions, please read "Order and dispatch of EDQM products".