Table XXI

Comparison of Total Available Elemental Impurities Versus Amount Extracted

Material	Elemental Impurity	Total Amount Available (mg/kg)	Extracted Amount (mg/kg unless noted)	Extraction Conditions	Ref.
ABS	Mg	220	0.005	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
ABS	Zn	1.5	<0.001		21
Glass	Sb	10	As high as 26 ng/L	Extracted levels are from commercial water samples stored in PET bottles	30
Glass (Type 1)	Si	80% as SiO₂	15 mg/L	Glass vials filled with water and extracted under autoclave conditions	41
	Na	4% as Na₂O	3 mg/L
	K	0.5% as K₂O	1 mg/L
	Al	2% as Al₂O₃	1 mg/L
Glass ampoule	Al	1.43% Al	149 ng/mL in solution	Glass ampoule filled with 20% NaCl, commercial product tested within expiry	45
Glass ampoule	Al	1.51% Al	5620 ng/mL in solution	Glass ampoule filled with 20% Na gluconate, commercial product within expiry	45
Plasticized PVC	Zn	520^¹	1.3 (pH 2.5), 0.43 (pH 9.5)	5 g of material per 200 mL of extracting solvent, 121 °C for 1 h, aqueous solvents	35
Plasticized PVC	Ca	320^¹	1.5 (pH 2.5), <0.1 (pH 9.5)		35
PVC IV bags	Zn	55	0.01–1 mg/L^⁴	150 mL of 0.9% saline in 150 mL bag, commercial product within stated shelf-life	17
PVC IV bags	Zn	68	0.08–0.24 mg/L^⁴		17
Polyester bottle	Ca	21	14	2% citric acid solvent, extraction conditions not specified	24
	Fe	2	<1
	Sb	151	7
	Ti	16	<1
	Zn	10	4
Polycarbonate Bottle	Ca	12	5	2% citric acid solvent, extraction conditions not specified	24
	Fe	<1	<1
	Ti	<1	<1
	Zn	13	2
Poly(methyl methacrylate)	Mg	5.2	0.001	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Zn	<1	0.004		21
	Zn	<1	0.008	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days	21
Low-density polyethylene	Mg	23^⁵	0.002^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Al	0.41^⁵	0.002^⁵
	Al	7.2^⁵	0.004^⁵
	Co	50	<0.005	Resin extracted; 28 cm^²/50 mL water, 3% acetic acid, ethanol; 40 °C for 10 days	44
	Cr	50	<0.090
	Sb	50	<0.004
	Zn	50	<0.52
PE ampoule	Al	400	13 ng/mL in solution	Ampoule filled with 20% NaCl, commercial product tested within expiry	45
High-density polyethylene	Al	0.51^⁵	v0.004^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Al	0.51^⁵	0.014^⁵	3 g of material per 20 mL of 15% ethanol acid, 40 °C for 10 days	21
	Cr	3.7^⁵	0.002^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Zr	42^⁵	<0.001^⁵		21
High-density polyethylene bottle^²	Al	89	9 (in 0.1 N HCl)^³	Extraction conditions not specified	24
	Ca	8	7 (in 2% citric acid)^³
	Fe	5	<1 (in all aolutions)^³
	Ti	3860	<1 (in all solutions)^³
	Zn	215	55 (in 2% citric acid)^³
Polypropylene	Al	26^⁵	<0.001^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
Polypropylene	Cr	1.3^⁵	<0.001^⁵		21
Polystyrene	Mg	23^⁵	<0.001^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Mg	23^⁵	5.2^⁵	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days
	Al	0.6^⁵	<0.001^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days
	Al	0.6^⁵	0.010^⁵	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days
	Co	0.6^⁵	<0.001^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days
	Co	0.6^⁵	0.001^⁵	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days
	Cu	16^⁵	0.004^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days
	Cu	16^⁵	0.028^⁵	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days
	Zn	3.0^⁵	0.035^⁵	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days
	Zn	3.0^⁵	0.650^⁵	3 g of material per 20 mL of 15% ethanol, 40 °C for 10 days
Polyethylene terephthalate	Mg	5.9	0.003	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days	21
	Al	620	<0.001		21
	Al	86–301^⁶	6–70 mg/L^⁶	Commercially available bottled soft drinks	47
	Co	33	<0.001	3 g of material per 20 mL of 3% acetic acid or 15% ethanol, 40 °C for 10 days	21
	Ge	14	<0.001	3 g of material per 20 mL of 3% acetic acid, 40 °C for 10 days
	Sb	160	0.003	3 g of material per 20 mL of 3% acetic acid or 15% ethanol, 40 °C for 10 days
	Mn	0.3–116^⁶	0.01–0.2 mg/L^⁶	Commercially available bottled soft drinks	47
	Sb	400	As high as 630 ng/L	Extracted levels are from commercial water samples stored in PET bottles	30
	Sb	200	0.008	Resin extracted; 28 cm^²/50 mL water, 3% acetic acid, ethanol; 40 °C for 10 days	44
Polyolefin IV bag	Zn	7.6	0.08–0.75 mg/L^⁴	100 mL of 0.9% saline in 250 mL bag, commercial product within shelf-life	17
Polyolefin IV bag	Zn	5.0	0.01 mg/L^⁴	250 mL of 0.9% saline in 250 mL bag, commercial product within shelf-life

Notes:
↵1 As zinc or calcium stearate, which was present in the material in known quantities.
↵2 This material contained a TiO₂ filler.
↵3 Highest value reported from three extracting solutions (water, 0.1 N HCl, and 2% citric acid).
↵4 As the weights of the IV bags were not specified, these units could not be converted to milligrams per kilogram (mg/kg).
↵5 Multiple materials and multiple solvents were used. The reported data is for those cases where the greatest portion of the total pool was extracted.
↵6 As the weights of the PET bottles were not specified, these units could not be converted to milligrams per kilogram (mg/kg). The range of result is for approximately 20 tested samples. Of the over 20 elements measured, the authors concluded that only Al and Mn were leached from the PET bottle.