EDQM: New General Chapter on Extractable Elements in Plastic Materials Adopted
While the European Pharmacopoeia (Ph. Eur.) already includes parts of the ICH Q3D guideline on elemental impurities in the general chapter on Elemental impurities (5.20), the requirements for extractable elements from plastic containers for pharmaceutical use and closures are legally binding.
Although plastics used the manufacture of containers for pharmaceutical use are not directly covered by ICH Q3D and the general chapter 5.20, their quality significantly impacts the final product. To address this, a new procedure to assess extractable elements in plastic materials has been developed and validated by Ph. Eur. Group 16. The resulting draft chapter, Extractable elements in plastic materials for pharmaceutical use (2.4.35), focuses on the analytical procedure for testing extractable elements and will be published in Supplement 11.7 (September 2024).
Source:
EDQM: Newsroom
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