Back Public consultation on a new general chapter 2.5.46. Phenolic antioxidants in plastic materials in Pharmeuropa 37.3

EDQM Strasbourg, France 17/07/2025
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Public consultation on a new general chapter 2.5.46. Phenolic antioxidants in plastic materials in Pharmeuropa 37.3

After several years of dedicated work by the experts of Group 16 (Plastic materials, plastic containers and closures), a new HPLC-UV analytical procedure has been developed to test for phenolic antioxidants in plastic materials and is described in the new general chapter 2.5.46. Phenolic antioxidants in plastic materials, published in Pharmeuropa 37.3.

The aim of this new, fully validated analytical procedure, which covers seven different plastic additives, is to simplify the testing of phenolic antioxidants in plastic materials using state-of-the-art liquid chromatography.

This single procedure given in the new general chapter is referenced in the following general chapters covering four plastic materials (published in the same issue of Pharmeuropa), replacing the two different existing analytical procedures (A and B) for phenolic antioxidants:

  • 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

Users are encouraged to comment on all five texts in Pharmeuropa 37.3 (deadline for comments: end of September 2025), viewing them as a package and considering whether a comment on one of them applies to the others as well.

For more information on how to comment, please consult our “How to comment” guide.

Comments from interested parties from member states of the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

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