Proposals for Ph. Eur.-Chapters on Rubber Closures & PVC Materials

Draft versions of the Ph. Eur. chapters on rubber closures and non-plasticised PVC materials have been published in Pharmeuropa Issue 38.1. The deadline for comments is 31 March 2026.

Proposed Changes

3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders

The text was previously published in Pharmeuropa 37.4 with changes proposed to the wording of the tests for extractable zinc, reducing substances and fragmentation. The text proposed now in issue 38.1 reproduces these modifications. Users are invited to comment only on the additional introduced change regarding volatile sulfides in the tests section. Following issues regarding the availability of sodium sulfide R, the reagent used so far in the test has been changed to thioacetamide R, which also improves the visibility of the test results.

3.1.11. Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration

Identification details have been added on the absorption maxima that can be observed if copolymers based on acrylic and/or methacrylic acids and/or their esters, and/or on styrene and/or butadiene are present in the material. In addition, typical spectra for some of the materials have also been included.

More information is available in Pharmeuropa online.