Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices.
A review is provided related to the accumulation of organic and inorganic leachable substances from DEHP-plasticized PVC, polyolefin and various other related pharmaceutical plastic packaging materials. The review considers both the identification of such leachables as well as their reported levels in actual and simulated pharmaceutical products.
Jenke
Dennis
D
Baxter Healthcare Corp., Route 120 and Wilson Road, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
D004051:Diethylhexyl Phthalate / Q000032:analysis / Q000737:chemistry; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging / Q000592:standards*; D010968:Plasticizers / Q000032:analysis / Q000737:chemistry*; D010969:Plastics / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry
D010968:Plasticizers; D010969:Plastics; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate