EDQM: Overview of Reference Substances updated

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 3100 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 according to Ph. Eur. methods.

In addition, the EDQM summarises in tabular form on its website which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances, for example through the implementation of supplement 11.3 (since January 2024) or will be deleted or replaced by supplements 11.4 and 11.5 in the future (from April and July 2024 respectively).

Information is also provided when the packaging units of the standards have been changed, such as for the Buserelin CRS, Phenazone impurity A CRS and Methylphenidate impurity C CRS standards, when the transport and storage conditions of the substances have been updated or when individual prices of some substances have been increased. It also reports on which international standards, the so-called "International Chemical Reference Substances (ICRS)" and "International Standards for Antibiotics (ISA)", have been removed from the catalogue. As at 31 December 2023, three ICRSs and none of the ISAs were affected.

Finally, a description of how reference substances can be ordered is provided and also presented in a video.

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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