EDQM: Excipient Monographs and Reference Standards

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

In the last few months, some excipient monographs have been updated and new reference standards have been added to the European Pharmacopoeia (Ph.Eur.). Supplement 11.6, which was introduced on the 1st January 2025, contains, for example, the revised texts of the following substances:

Polysorbate 20
Polysorbate 40
Polysorbate 60
Polysorbate 80
Propylene glycol

Several other monographs have also been revised and submitted for comment. These revisions and updates are intended to contribute to the increased use of modern IR techniques for identification and CRS (Chemical Reference Substances).

Further information can be found in the Newsroom of the EDQM website.