Phenolic Antioxidants in Plastic Materials
Recommendation

19/20 May 2026
All relevant GMP/GACP aspects for Medical Cannabis
A new European Pharmacopoeia (Ph. Eur.) chapter 2.5.46. Phenolic antioxidants in plastic materials has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.
Scope
The general chapter describes the analytical procedure (Liquid Chromatography) for determining the concentration of phenolic antioxidants in polymers.
As the analytical procedure replaces the analytical procedures for phenolic antioxidants currently described in several plastic materials chapters, the new general chapter should be read in conjunction with the following Ph. Eur. texts:
- 3.1.3 Polyolefins
- 3.1.5 Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations
- 3.1.6 Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations
- 3.1.7 Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations
For more information please go to Pharmeuropa online.
Related GMP News
22.04.2026Roadmap for the Introduction of the Electronic Package Leaflet
15.04.2026Revision of Ph. Eur. Chapter on Extractables in Plastic Materials
08.04.2026What are the GMP Requirements for Pharmaceutical Packaging Materials?
26.03.2026ICH Q3E: EMA publishes Comments Received
11.03.2026Revised USP Chapter <382> Elastomeric Component Functional Suitability
04.03.2026Revised USP Chapter <661> Plastic Packaging Systems and Their Materials of Construction


