EDQM: New Reference Standards available

The list of available reference standards is revised and published at regular intervals on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare). This comprises more than 3000 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods. The following five substances have now been added:

• Chloroxylenol CRS  
• Etravirine CRS  
• Etravirine for peak identification 
• Etravirine for system suitability 
• Bromperidol for system suitability CRS

In addition, the EDQM summarises in a table on its website which reference substances have been replaced by new batches. This currently concerns 20 substances.

Standards are also listed that have been removed from the list of reference substances, for example through the implementation of addendum 11.3 (since January 2024) and addendum 11.4 (since April 2024) or will be deleted or replaced by addendum 11.5 in the future (from July 2024).

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