Table X

Extracted Elemental Impurities Reported for Polypropylene (PP)

ElementConcentration (mg/kg unless noted)Extraction DetailsCommentsRef.
SolventConditions
AlNR1–1.1Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–0.04High pH (≈9)
NR–0.27Ethanol/water
0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 115 mg/kg21
BNR–4.9Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–0.93High pH (≈9)
NR–1.1Ethanol/water
BaNR–1.7Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–1.1High pH (≈9)
NREthanol/water
0.3pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440
CaNR–7.0Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–0.98High pH (≈9)
NR–4.2Ethanol/water
0.3pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440
Cr<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 1.3 mg/kg21
FeNR–0.20Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–0.02High pH (≈9)
NREthanol/water
MgNR–0.10Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–0.80High pH (≈9)
NR–0.10Ethanol/water
0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 23 mg/kg10
<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440
NaNR–17Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NA2High pH (≈9)
NR–1.3Ethanol/water
PNR–0.59Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NAHigh pH (≈9)
NR–0.69Ethanol/water
SNR–2.3Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–12High pH (≈9)
NR–0.43Ethanol/water
SiNR–3.1Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–2.7High pH (≈9)
NR–0.90Ethanol/water
Sr<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440
ZnNR–0.22Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.04–0.40 g sample/mL solvent19 materials tested; resins, parts312
NR–1.5High pH (≈9)
NR–0.02Ethanol/water
0.3pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440
Zr<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe440

  • Notes:

  • ↵1 NR = Not reported: not extracted at reportable levels (generally less than 0.01 μg/g).

  • ↵2 NA = Not applicable; element was a component of the extracting solvent.

  • ↵3 Elements that were not extracted in reportable levels included Ag, As, Be, Bi, Cd, Co, Cr, Cu, Ge, Li, Mn, Mo, Ni, Pb, Sb, Se, Sn, Sr, Ti, V, and Zr.

  • ↵4 Elements that were not extracted in reportable levels, generally 1 μg/g, included Ag, As, Bi, Co, Cr, Cu, Mo, Ni, Sb, Se, Sn, and V.