New Ph. Eur. Chapters on COC, COP and SBC approved
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Following the new Ph. Eur. Chapter 2.4.35 on Elemental Impurities in Plastic Materials (published in Ph. Eur. Supplement 11.7), the European Pharmacopoeia Commission (EPC) approved the following 3 new Ph. Eur. plastic chapters for containers:
- 3.1.17. Cyclo-Olefin Copolymers (COC),
- 3.1.16. Cyclo-Olefin Polymers (COP), and
- 3.1.18. Styrene Block Copolymers (SBC).
The new general chapters provide specifications for COC, COP and SBC materials, used in the manufacture of containers for pharmaceutical use. The texts will be published in the 12th Edition of the Ph. Eur. They will become effective as of 1 January 2026.
With the addition of cyclo-olefin polymers, cyclo-olefin copolymers and styrene block copolymers, the Ph. Eur. now covers a total of 14 different materials used in the manufacture of containers for pharmaceutical uses.
More information is available in Outcome of the 180th session of the European Pharmacopoeia Commission, published in the EDQM Newsroom.
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