April 2025 News Bulletin

MAKING PHARMACEUTICALS 2025 

We are again exhibiting at Making Pharmaceuticals and we look forward to seeing old friends and meeting potential new clients.  If you are attending the event at the Coventry Arena, please come and talk to us on Stand 315 or, if you would like to arrange a specific time, email us.

Sustainability is a key topic for us and also for many of our clients, and it is pleasing to see that Steam A of the Conference Programme contains several presentations and a Panel Discussion on this important subject.

NEW GAS CHROMATOGRAPHY INSTRUMENTS

We have completed the commissioning of one of the two recently delivered Shimadzu GCs.  The second, which will feature the new Dielectric-Barrier Discharge Ionization Detector (BID) is planned to be completed by early May.  

The new detector will allow us to detect compounds, such as those without a strong UV chromophore or which have poor ionisation,  at levels which are not possible or difficult using traditional detectors. This will make it particularly useful for Residual Solvent testing to ICHQ3C. 

For more information on our current GC services, click here.

HELIUM SHORTAGE 4.0

With preparations well underway for the Making Pharma 2025 conference in April, Frank Judge thought it was a good time to provide an update to his presentation on the helium shortage, which was well-received at the same conference in 2024. 

Click here to read his Blog

MODERNISING EXCIPIENT MONOGRAPHS

From the EDQM Newsroom: Revised identification techniques and new CRSs.

In recent months, several revised excipient monographs and new reference standards have been added to the European Pharmacopoeia (Ph. Eur.). The changes aim 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.

Butterworth Laboratories is aware of these changes and has the relevant CRSs.