In recent months, several revised excipient monographs and new reference standards have been added to the European Pharmacopoeia (Ph. Eur.). The aim of the changes is to support users by promoting modern IR identification techniques and replacing reference spectra with chemical reference substances (CRS).

The following revised texts were published in Supplement 11.6, with an implementation date of 1 January 2025:

• Polysorbate 20 (0426), Polysorbate 40 (1914), Polysorbate 60 (0427) and the widely used Polysorbate 80 (0428), all of which now describe an IR identification by CRSs;
• Propylene glycol (0430), which describes a new IR identification using Propylene glycol for identification CRS instead of the previous mix of chemical and physical tests.

This modernisation work has continued with the monograph on Carnauba wax (0597), describing an IR identification instead of the original TLC test, and both Beeswax, white (0069) and Beeswax, yellow (0070), which now include an identification test, all published in Pharmeuropa 36.4 for comment. These follow Macrogolglycerol ricinoleate (1082) and Macrogolglycerol hydroxystearate (1083), revised to introduce an IR identification avoiding the use of the mercury-containing solutions described in one of the identification tests, and published in Pharmeuropa 36.2.

All Ph. Eur. reference standards undergo extensive testing tailored to ensure fitness for purpose, and can be purchased from the EDQM, either:

• via the web store, where you can also confirm a proforma invoice or quotation you have already received from the EDQM;
• or by sending an email to [email protected], attaching your order (on your company letter-headed paper, stating both the catalogue code and substance name).