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Elemental impurities in plastic materials: extension of Pharmeuropa commenting period for chapter 2.4.35

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European Pharmacopoeia
Public enquiry
News
26 June 2020
Strasbourg, France

Due to high public interest and the importance of the text, it has been decided to extend the consultation period for the new general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) to give stakeholders more time to comment. Originally published in Pharmeuropa 32.2, this draft chapter covers elemental impurities that may be present in plastic materials used in the manufacture of containers for pharmaceutical preparations. It will now be published in Pharmeuropa 32.3, thereby extending the deadline for comments until 30 September 2020.

The new chapter is accompanied by a supporting information document explaining the text and its raison d’être. It shows that while elemental impurities in plastic materials are not directly within the scope of the existing texts on elemental impurities (ICH Q3D guideline and European Pharmacopoeia chapter 5.20. Elemental impurities), their impact on the quality of the containers produced from these materials is to be taken into account, hence the new draft general chapter. Consult the supporting information document to find out more.

Two other new general chapters on specific plastic materials, Cyclo-olefin polymers (3.1.16) and Cyclo-olefin copolymers (3.1.17), were also first published in Pharmeuropa 32.2. Both refer to the general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) and are to be read in conjunction with it. These two new texts have therefore also been republished, unchanged, in Pharmeuropa 32.3 to extend the deadline for comments.

Stakeholders are kindly asked to provide their comments by 30 September 2020 for all three general chapters.

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