6/7 June 2023
A revised draft for the recently proposed Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published in Pharmeuropa 34.1. The proposed general chapter has already undergone public consultation in Pharmeuropa 32.3.
The proposed new general chapters provide specifications for COC / COP materials, used in the manufacture of containers for pharmaceutical use (for example prefillable syringes). They include requirements for extractable elemental impurities.
In the updated version for COC, an additional testing procedure for amides using Thin-layer chromatography (Ph. Eur. 2.2.27) has been introduced as alkanamides and alkenamides are listed as additives for the material.
According to the EDQM, stakeholders are encouraged to provide feedback only on this proposed test. Comments received when the text was published in Pharmeuropa 32.3 have already been evaluated by experts. The public deadline for comments is 31 March 2022.
More information can be found on the Pharmeuropa website.