Wednesday, 21 March 2018

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


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.
For further details, see Ph. Eur.

Posted by Dr. Tim Sandle

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