EDQM: List of Reference Standards Updated
Recommendation
18-20 November 2024
ICH Q7 in modern API Manufacturing – what to do and how to do
As we recently reported, the list of available reference standards is revised at regular intervals and published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare). In April 2022, the list, which includes more than 3,000 substances, was updated again and the resulting changes and innovations were listed in the Newsroom of the EDQM website.
In the most recent list, 24 reference standards were replaced by new batches, and some substances have been removed from the list of reference substances or will be deleted in the future (as of July 2022). For all these substances, a transitional period of one year has been granted until they are completely removed from the list, and they are still available for purchase for a certain defined period of time. There was also a price change for one batch of a standard and changes to the transport and storage conditions for three substances. In addition, the packaging units of two standards were changed or extended.
The complete list of all available reference standards and the substances affected by the updates can be found on the EDQM website.
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