Table XX

Summary of Reported Occurrences for the “Second Tier” ICH Q3D Class 2A Metals (Co, Mo, Se, V) in Material Extracts

Type of TestConcentration (mg/kg unless noted)Extraction ConditionsMaterial and Sample TypeRef.
SolventConditions
Cobalt (Co)
Extraction0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g/mL solventPolyethylene resin35
<0.01pH 9.5
<0.005Water, olive oil, 3% acetic acid, ethanolSealed vessel, 40 °C for 10 days, 28 cm2 per 50 mL solventPolyethylene resin, total pool of Co = 50 mg/kg44
<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventPolystyrene, total pool = 0.6 mg/kg21
<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventPolyethylene terephthalate, total pool = 58 mg/kg21
Molybdenum (Mo)
Extraction<0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g/mL solventPlasticized PVC resin35
0.01pH 9.5
1–55 ng/mL4EthanolFilled portions of silicone tubing, 55 °C for 24 h6 commercially available silicone materials54
Selenium (Se)
Extraction0.4IPA/waterVarious extraction methods, 0.02–0.04 g/mL solventPlasticized PVC resin56
0.6pH 9.5
0.6Isohexane
Vanadium (V)
Extraction0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g/mL solventPlasticized PVC resin35
<0.01pH 9.5
0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g/mL solventRubber elastomer strip35
0.01pH 9.5Sealed vessel, 121 °C for 1 h, 0.025 g/mL solventRubber elastomer strip35