Table XVII

Summary of the Total Amount of Elemental Impurities in Materials; ICH Q3D Class 1 Elements (As, Cd, Hg, Pb)

Element	Material	Total Amount in Material (mg/kg)	Reference
Arsenic (As)	PE/PET/PE laminate film	<0.001	48
	Type 1 glass	0.3	24
	Polycarbonate bottle	<0.5	24
	Polyester bottle	<0.5	24
	Polyethylene terephthalate (17 bottles tested)	1–4	47
	Polyethylene terephthalate	<0.04	49
	Polyethylene terephthalate	<0.04	49
	Low-density Polyethylene	<1.3	26
	Polyethylene reference standard	<1	20
	Polyethylene (5 samples)	≤0.001	60
	High-density polyethylene	<0.5	24
	High-density polyethylene	<1.3	26
	High-density polyethylene	<1.3	26
	High-density polyethylene	<0.003	49
	Polyethylene/polypropylene blend	<1.3	26
	Polypropylene	<0.001	48
	Polypropylene	0.009	49
	Polypropylene (5 samples)	<0.001–0.10	60
	Polystyrene	<0.005	49
	Polystyrene (white)	0.011	49
	Bromobutyl rubber	3.0	24
	Prefilled syringe, barrel, and plunger	<0.5	24
Cadmium (Cd)	PE/PET/PE laminate film	<0.001	48
	Cardboard	<0.01	31
	Cardboard + polyethylene film	25	31
	Paper (3 samples)	<0.01–0.12	33
	Paperboard (3 samples)	<0.01–0.09	33
	Type 1 glass	0.5	33
	Polycarbonate bottle	<0.5	24
	Polyester bottle	<0.5	24
	Polyethylene terephthalate	<1.3	27
	Polyethylene terephthalate	3.5	28
	Polyethylene terephthalate	<0.1	29
	Polyethylene terephthalate	0.02	31
	Polyethylene terephthalate	<2	49
	Low-density polyethylene	<0.38	26
	Low-density polyethylene	<0.26	49
	Polyethylene	<0.1	29
	Polyethylene	<0.01	31
	Polyethylene	<1.3	27
	Polyethylene (5 samples)	<0.05	60
	Polyethylene	0.14	61
	High-density polyethylene	<0.01	31
	High-density polyethylene	<0.5	24
	High-density polyethylene	113	26
	High-density polyethylene	<0.38	26
	High-density polyethylene	<0.25	49
	Polyethylene/polypropylene blend	<0.38	26
	Polypropylene	<1.3	30
	Polypropylene	0.01	31
	Polypropylene	<0.001	48
	Polypropylene	<0.29	49
	Polystyrene	<1.3	27
Cadmium (Cd)	Polystyrene	<0.29	49
	Polystyrene	0.02	31
	Polytetrafluoroethylene (3 samples)	<0.01	32
	Bromobutyl rubber	<0.1	24
	Multi-layered polyolefin film	0.04	31
	Multi-layered polyolefin film	<0.01	31
	Prefilled syringe, barrel, and plunger	<0.5	24
	Polyvinyl chloride	80, 112	58
	Polyvinyl chloride	65	59
Mercury (Hg)	Cardboard	<0.02	31
	Cardboard + polyethylene film	0.06	31
	Type 1 glass	<0.5	24
	Polycarbonate bottle	<0.5	24
	Polyester bottle	<0.5	24
	Polyethylene terephthalate	<1	28
	Polyethylene terephthalate	<0.02	31
	Polyethylene terephthalate	<1.3	49
	Low-density polyethylene	<0.88	26
	Low-density polyethylene	<0.06	49
	Polyethylene	0.01	31
	Polyethylene (5 samples)	<0.003	60
	High-density polyethylene	<0.02	31
	High-density polyethylene	<0.5	24
	High-density polyethylene	<0.88	26
	High-density polyethylene	<0.88	26
	High-density polyethylene	<0.046	49
	Polyethylene/polypropylene blend	<0.88	26
	Polypropylene	<0.02	31
	Polypropylene	<0.11	49
	Polystyrene	0.03	31
	Polystyrene	<0.013	49
	Whit polystyrene	<0.05	49
	Multi-layered polyolefin film	<0.02	31
	Multi-layered polyolefin film	<0.02	31
	Prefilled syringe, barrel, and plunger	<0.5	24
Lead (Pb)	PE/PET/PE laminate film	0.53	48
	Acrylonitrile-butadiene-styrene copolymer	0.76	43
	Acrylonitrile-butadiene-styrene copolymer	0.76	13, 14
	Cardboard	0.38	31
	Cardboard + polyethylene film	1.5	31
	Paper (3 samples)	028–0.35	33
	Paperboard (3 samples)	0.67–0.99	33
	Type 1 glass	1.0	24
	Polycarbonate bottle	<0.1	24
	Polyester bottle	<0.1	24
	Polyethylene terephthalate	0.24	13, 14
	Polyethylene terephthalate	<0.01	27
	Polyethylene terephthalate	<0.01	29
	Polyethylene terephthalate	0.15	31
	Polyethylene terephthalate (2 samples)	<0.01, 0.24	43
	Polyethylene terephthalate (17 bottles tested)	2–9	47
Lead (Pb)	Low-density polyethylene	1.28	26
	Low-density polyethylene	<0.01	43
	Polyethylene	<0.1	29
	Polyethylene	0.1	31
	Polyethylene	<1	20
	Polyethylene	<3.9	27
	Polyethylene	0.76	61
	High-density polyethylene	4.1	13, 14
	High-density polyethylene	0.11	43
	High-density polyethylene	<0.1	24
	High-density polyethylene	1222	26
	High-density polyethylene	<0.13	26
	High-density polyethylene (7 samples)	<0.01–4.1	43
	Polypropylene	5.5	27
	Polypropylene	0.32	31
	Polypropylene	<0.01	43
	Polypropylene	1.06	48
	Polypropylene/polyethylene blend	160	26
	Polystyrene	<3.9	27
	Polystyrene	0.62	31
	Polystyrene	<0.01	43
	Polymethylmethacrylate	<0.01	43
	Bromobutyl rubber	1.1	24
	Laminated polyolefin	1.1	13, 14
	Laminated polyolefin	1.1	13, 14
	Multi-layered polyolefin	0.21	31
	Multi-layered polyolefin	0.08	31
	Prefilled syringe, barrel and plunger	<5	24
	Polyvinyl chloride (2 samples)	112, 157	58