TABLE II

Description of the Test Materials Used in the Chemistry Team Controlled Extraction Study

Test MaterialsArticleCompositionApplicationCategory
Bromobutyl Rubber (BIIR)Compression Molded Sheet• Brominated Isobutylene Isoprene Copolymer (57.3%)Closures Plungers GasketsSVP or LVP for Multiple Doses per Day
• Calcined Aluminum Silicate (38.2%)
• Titanium Dioxide (1.2%)
• Zinc Oxide, (0.6%)
• Polyethylene (0.6%)
• Carbon Black (0.4%)
• Calcined Magnesium Oxide (0.3%)
• Morpholine/polyisobutylene (0.3%)
Polyvinyl Chloride (PVC)Pellets• PVC ResinBags TubingLVP
• DEHP (30%)
• Epoxidized Soybean Oil (7%)
• Zn Stearate (0.5%)
• Ca Stearate (0.5%)
• Stearamide (1%)
Low-Density Polyethylene (LDPE)Blown Film• Irganox B215 (Irgaphos 168 and Irganox 1010 BlendOver-pouch BFS ContainersBFS, SVP, LVP
•(1000 ppm)
• BHT (200 ppm)
• Calcium Stearate (500 ppm)
• Erucamide (500 ppm)
• Chimassorb 944 (2000 ppm)
Cyclic Olefin Copolymer (COC)PlaquesIrganox 1010 Ultramarine BlueSyringes VialsPVS, SVP or LVP for Multiple Doses per Day
Polycarbonate (PC)Injection Molded PlaquesIrganox 1076 (0.05 PHR)Ports TubesLVP
Irgaphos 168 (0.1 PHR)