Revision of Ph. Eur. Chapter on Extractables in Plastic Materials

The European Pharmacopoeia (Ph. Eur.) chapter 2.4.35 Extractable elements in plastic materials for pharmaceutical use has been revised (Issue 13.1). It will be effective as from 1 January 2027.

Determination

To enhance the clarity of the text, a non-exhaustive list of elements has been included in the "Determination" section:

"Perform the test using a suitable internal standard that does not interfere with the signals of the elements to be determined (e.g. antimony, arsenic, cadmium, cobalt, copper, lead, lithium, mercury, nickel, vanadium). Examine by inductively coupled plasma-mass spectrometry (ICP-MS) (Ph. Eur. 2.2.58)."

The new nine-month implementation period starts with Ph. Eur. Issue 13.1. Thus, the revised version will come into force on 1 January 2027 at the latest, and must be implemented by this date.

More information is available in the European Pharmacopoeia Online.