These “Class 1” elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for pharmaceutical use and require evaluation during the risk assessment across all potential sources of elemental impurities and routes of administration; the new reference standards underpin the European Pharmacopoeia (Ph. Eur.) chapter describing the determination of elemental impurities (2.4.20.).
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.
If you wish to place an order, you can send your request to the EDQM either:
- through the web store (this RS Order form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM).
- or by email to email@example.com (in this case, please ensure that your order is on your company letter headed paper stating both the catalogue code and substance name and attached to your email).