EDQM: Availability of Reference Standards

Global Registration and Life Cycle Management for APIs

Recommendation

8-10 April 2025
Vienna, Austria

Global Registration and Life Cycle Management for APIs
Contents of the regulatory information in the ASMF and CEP

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at a regular basis. This list comprises more than 3000 substances, including chemical reference substances, herbal reference standards and biological reference preparations, as well as reference spectra for performing tests and assys according to Ph. Eur. methods.

In addition, the EDQM summarises in tabular form on its website which reference standards have been replaced by new batches and which substances have been removed from the list of reference substances (since January 2022) or will be deleted in future (from April or July 2022 onwards).

The website also provides information on changes related to the sales units of the standards, on updates of the transport and storage conditions of the substances as well as on special announcements regarding the prices of the substances.

Finally, it is described and additionally presented in a video how reference substances can be ordered.

The complete list of all available reference standards and the substances affected by the updates can be found on the EDQM website.