Table XII

Extracted Elemental Impurities Reported for Silicones (SI)

Element	Concentration (mg/kg unless noted)	Extraction Details		Comments	Ref.
Element	Concentration (mg/kg unless noted)	Solvent	Conditions	Comments	Ref.
Ag	1–51 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Al	NR^¹–0.52	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR	High pH (≈9)
	NR	Ethanol/water
As	1–38 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
B	NR–1.7	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–2.1	High pH (≈9)
	NR–4.8	Ethanol/water
	39–484 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Ca	NR–1.9	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–2.2	High pH (≈9)
	NR–1.1	Ethanol/water
	1–19 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Cr	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–0.60	High pH (≈9)
	NR	Ethanol/water
Cu	1–34 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Fe	NR–0.20	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–0.04	High pH (≈9)
	NR–0.06	Ethanol/water
Li	1–93 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Mg	NR–0.15	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–0.23	High pH (≈9)
	NR–0.30	Ethanol/water
Mn	1–83 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Mo	1–55 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Na	NR–1.8	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NA^²	High pH (≈9)
	NR–14	Ethanol/water
Ni	1–98 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
P	NR–0.33	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NA	High pH (≈9)
	NR–1.7	Ethanol/water
Pt	1–58 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55°C for 24 h	6 commercially available materials	54
S	NR–2.3	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	NR–1.9	High pH (≈9)
	NR–12	Ethanol/water
Si	8.4–490	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–0.20 g sample/mL solvent	6 materials tested; tubing, parts^³	12
	9.8–440	High pH (≈9)
	28–260	Ethanol/water
	31–35 mg/L	1% Trition X	Sealed vessel, 37 °C for 18 days	Total pool of silicon ≈6 weight %	53
Sb	1–35 ng/mL^⁴	Ethanol	Filled portions of silicone tubing, 55 °C for 24 h	6 commercially available materials	54
Sn	1–53 ng/mL^⁴	Ethanol
Ti	1–65 ng/mL^⁴	Ethanol
Zr	1–79 ng/mL^⁴	Ethanol

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, Ba, Be, Bi, Cd, Co, Cr, Cu, Ge, Li, Mn, Mo, Ni, Pb, Sb, Se, Sn, Sr, Ti, V, Zn, and Zr.
↵4 The result of 1 ng/mL is the approximate quantitation limit for the determination of extracted levels of the respective elements.