Four new plasticisers now added to the European Pharmacopeia

The EDQM has just announced that four new plasticisers have been added to the European Pharmacopoeia for containers for human blood and blood components, tubing used in sets for the transfusion of blood and blood components, empty sterile containers of plasticised PVC for human blood and blood components, and sterile containers of plasticised PVC for human blood containing anticoagulant solution. The new plasticisers are:

• Hexamoll® DINCH (cyclohexane 1,2-dicarboxylic acid, diisononyl ester)
• BTHC (butyryl tri-n-hexyl citrate)
• TOTM (tris(2-ethylhexyl) trimellitate)
• DEHT (bis(2-ethylhexyl) terephthalate)

This means medical manufacturers now have several alternatives to DEHP plasticiser available, which are all included in the Pharmacopeia.