EDQM: Availability of Reference Substances
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Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
The list of available reference standards is regularly revised and published on the EDQM website. The list comprises more than 3,000 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 four substances were added in July 2024:
- Golimumab CRS
- Ursodoxicoltaurine dihydrate CRS
- Atorvastatin for peak identification C CRS
- Ursodoxicoltaurine impurity A CRS
On its website, the EDQM also summarises in a table which reference substances have been replaced by new batches. This currently applies to 19 substances.
Standards are also listed that have been removed from the list of reference substances, for example through the implementation of supplement 11.4 (since April 2024) and supplement 11.5 (since July 2024) or will be deleted or replaced by supplement 11.6 in the future (as of January 2025).
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.
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