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The Ph. Eur. revised its general chapters on plasticised PVC materials

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European Pharmacopoeia
General text/chapter
News
18 January 2018
Strasbourg, France

At its 159th Commission session (November 2017) the Ph. Eur. Commission adopted the following revised general chapters:

- 3.1.1.1/90001. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components;
- 3.1.1.2/90002. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components;
- 3.2.4. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components;
- 3.2.5. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution.

 

These chapters had been revised to include four new PVC plasticisers:

- cyclohexane 1,2-dicarboxylic acid, diisononyl ester;
- butyryl tri-n-hexyl citrate;
- tris(2-ethylhexyl) trimellitate;
- bis(2-ethylhexyl) terephthalate.

 

Another 2 general chapters were also indirectly impacted by the revision:

- 3.1.13. Plastic additives: the list of additives has been updated with the 4 additives mentioned above;
- 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion: the quantification of plasticisers (including DEHP) is now performed by gas chromatography/mass spectrometry.

 

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