Phenolic Antioxidants in Plastic Materials

Recommendation
14/15 October 2025
Understanding the Importance of GMP
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.
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