Table IV

Extracted Elemental Impurities Reported for Glass

Element	Concentration (mg/kg unless noted)	Extraction Details		Comments	Ref.
Element	Concentration (mg/kg unless noted)	Solvent	Conditions	Comments	Ref.
Al	NR^¹–0.90	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–2.6	High pH (≈9)
	NR	Ethanol/water
	4.7 mg/L	0.1% ethylenediaminetetraacetic acid (EDTA)	Filled vials, 60 °C for 23 weeks	Type 1 clear glass vials^⁴	23
	0.53 mg/L	Water
	0.18 mg/L	0.2% Polysorbate 80
	0.08 mg/L	pH 6.8 buffer
	0.39 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
	0.56 mg/L	Water
	0.16 mg/L	pH 6.8 buffer
	0.16 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 SiO₂-coated glass vial^⁴	23
	0.18 mg/L	pH 6.8 buffer	Filled vials, 60 °C for 23 weeks	Type 1 SiO₂-coated glass vial^⁴	23
	0.4 mg/L	Water	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
	1 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
	15–65 ng/mL	Water	Filled ampoules, 121 °C for 30 min	12 ampoules tested	45
	150–1450 ng/mL	0.5% inorganic salts	Filled ampoules, 121 °C for 30 min	Al levels varied with salt used; more Al = higher pH of solvent^⁷	45
	100–420 ng/mL	Amino acids (0.5%)	Filled ampoules, 121 °C for 30 min	Al levels were fairly consistent across the acids	45
	4500 ng/mL	0.5% NaOH	Filled ampoules, 121 °C for 30 min	Substantial Al leaching	45
	320 ng/mL	0.5% EDTA	Filled ampoules, 121 °C for 30 min	No comments	45
	153 ng/mL	5% human serum albumin	Filled vials, 20 °C for 1 month	Unsiliconized Type 1 glass	52
	108 ng/mL	5% human serum albumin	Filled vials, 20 °C for 1 month	Siliconized Type 1 glass	52
As	0.55 ng/mL	Water	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
B	NR–1.7	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–68	High pH (≈9)
	NR–0.39	Ethanol/water
Ba	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–14	High pH (≈9)
	NR	Ethanol/water
	0.3	pH 2–12	Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solvent	Component of prefilled syringe^⁶	40
	1 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
Cr	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–0.10	High pH (≈9)
	NR	Ethanol/water
Ca	NR–0.70	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–4.6	High pH (≈9)		5 materials tested; vials and parts^³	12
	NR–0.70	Ethanol/water	Filled vials, 60 °C for 23 weeks	Type 1 clear glass vials^⁴	23
	0.16 mg/L	0.1% EDTA
	0.13 mg/L	pH 6.8 buffer
	0.01 mg/L	Water	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
	0.19 mg/L	0.1 % EDTA
	0.04 mg/L	pH 6.8 buffer
	0.01 mg/L	pH 6.8 buffer	Filled vials, 60 °C for 23 weeks	Type 1 SiO₂-coated glass vial^⁴	23
	0.3	pH 2–12	Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solvent	Component of prefilled syringe^⁶	40
	1 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
Fe	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR	High pH (≈9)
	NR	Ethanol/water
	0.56 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
K	1 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
Mg	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–2.4	High pH (≈9)
	NR	Ethanol/water
	0.14 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 clear glass vials^⁴	23
	0.05 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
	<0.1	pH 2–12	Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solvent	Component of prefilled syringe^⁶	40
	0.1 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
Mn	0.05 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
Na	NR–24	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NA	High pH (≈9)
	NR–0.88	Ethanol/water
	0.98 mg/L	Water	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
	3 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
P	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NA	High pH (≈9)
	NR	Ethanol/water
S	NR–0.34	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–0.18	High pH (≈9)
	NR	Ethanol/water
Sb	NR	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–4.1	High pH (≈9)
	NR	Ethanol/water
	10–130 μg/L	Water	Filled bottles, commercial product	Total pool = 7–10 mg/kg	51
Pb	NR–17	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR–2.6	High pH (≈9)
	NR	Ethanol/water
	0.06 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 clear glass vials^⁴	23
	0.02 mg/L	Water	Filled vials, 60 °C for 23 weeks	Type 1 clear glass vials^⁴	23
	0.04 mg/L	pH 6.8 buffer	Filled vials, 60 °C for 23 weeks	Type 1 amber glass vials^⁴	23
	0.04 mg/L	0.1% EDTA
	0.03 mg/L	pH 6.8 buffer
	0.02 mg/L	0.1% EDTA	Filled vials, 60 °C for 23 weeks	Type 1 SiO₂-coated glass vial^⁴	23
	0.01 mg/L	Water
	0.01 mg/L	pH 6.8 buffer
Si	NR–3.8	Low pH (≈3)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	1.1–670	High pH (≈9)
	0.39–11	Ethanol/water
	3.29 mg/L	Water	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
	20.8 mg/L as SiO₂	Water
	64.2 mg/L as SiO₂	0.9% KCl
	149 mg/L as SiO₂	Glutaric acid, pH 8	Vials; 2 h at autoclave (121 °C)	Highest value for multiple vials	37
	199 mg/L as SiO₂	Citric acid, pH 8	Vials; 2 h at autoclave (121 °C)	Highest value for multiple vials	37
	150 mg/L	tris(hydroxymethyl)aminomethane (TRIS), pH 8	Glass powder, 3 days at 90 °C, 0.01 g sample/mL	Value is silica solubility limit	38
	15 mg/L	Water	Autoclave cycle, filled vial	Type 1 30 mL vial	41
Sr	<0.1	pH 2–12	Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solvent	Component of prefilled syringe^⁶	40
W	0.23 mg/L	Water	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
Zn	NR	Low pH (≈3)	Glass syringe, 70 °C for 96 h	Mean result for Type A syringes^⁵	25
	NR	High pH (≈9)	Sealed vessel, 55 °C for 4 days, 0.1–1.0 g sample/mL solvent	5 materials tested; vials and parts^³	12
	NR	Ethanol/water
	0.3	pH 2–12
Zr	<0.1	pH 2–12	Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solvent	Component of prefilled syringe^⁶	40

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, Cu, Ge, Li, Mn, Mo, Ni, Se, Sn, Sr, Ti, V, and Zr.
↵4 Elements that were extracted in reportable levels included Cd, Co, Cr, Cu, Fe, Mn, Ni, V, and Zn (unless otherwise noted).
↵5 Elements which were not extracted in quantifiable amounts (generally 0.2 ng/mL or lower) included Cd, Cr, Cu, Hg, Ir, Mn, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru, and V.
↵6 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.
↵7 The lowest Al levels were for acidic salts (e.g., NaCl, ZnSO₄). The highest levels were obtained for basic salts such as NaHCO₃, K₂HPO₄, and sodium gluconate.