Table XIX

Summary of the Total Amount of Elemental Impurities in Materials; ICH Q3D Class 2A Elements (Co, Mo, Se, V)

Element	Material	Total Amount in Material (mg/kg)	Reference
Cobalt (Co)^¹	Acrylonitrile-butadiene-styrene copolymer	<0.01	43
	Type 1 glass	<0.1	24
	Colorless glass	3.6	57
	Polycarbonate bottle	<0.1	24
	Polyester bottle	<0.1	24
	Polyethylene terephthalate	58	13, 14
	Polyethylene terephthalate	35	13, 14
	Polyethylene terephthalate	17	13, 14
	Polyethylene terephthalate	33, 58	21
	Polyethylene terephthalate	14	28
	Polyethylene terephthalate	15, 58	43
	Polyethylene terephthalate (17 bottles tested)	0.5–59	47
	Polyethylene terephthalate	35	49
	Polyethylene terephthalate	17	49
	Low-density polyethylene	<0.001	43
	Low-density polyethylene	<0.001	49
	High-density polyethylene	<0.1	24
	High-density polyethylene	<0.001	43
	High-density polyethylene	<0.002	49
	Polyethylene (5 samples)	0.003–0.009	60
	Polypropylene	<0.005	49
	Polypropylene (5 samples)	<0.001–0.007	60
	Polystyrene	0.59	13, 14
	Polystyrene	0.60	21
	Polystyrene	<0.01	43
	Polystyrene	<0.003	49
	Polystyrene (white)	0.068	49
	Polymethylmethacrylate	<0.01	43
	Polytetrafluoroethylene	<0.01	32
	Polytetrafluoroethylene	<0.01	32
	Polytetrafluoroethylene	<0.01	32
	Bromobutyl rubber	0.2	29
	Prefilled syringe, barrel, and plunger	<0.5	24
Molybdenum (Mo)^¹	Type 1 glass	4.8	24
	Colored glass	16	57
	Polyethylene terephthalate	<0.93	49
	Polyethylene terephthalate	<0.1	49
	Low-density polyethylene	<0.36	26
	Low-density polyethylene	<0.11	49
	High-density polyethylene	<0.36	26
	High-density polyethylene	<0.36	26
	High-density polyethylene	<0.12	49
	Polypropylene	<0.1	48
	Polypropylene	<0.10	49
	Polypropylene/polyethylene blend	2.1	26
	Polystyrene	<0.13	49
	Polystyrene (white)	<0.1	49
	Bromobutyl rubber	<0.1	24
	Prefilled syringe, barrel, and plunger	<0.5	24
Selenium (Se)^¹	Type 1 glass	0.1	24
	Colored glass	1.5	57
	Polyethylene terephthalate	<2.7	49
	Polyethylene terephthalate	<0.1	49
	Low-density polyethylene	<0.2	49
	High-density polyethylene	<0.2	49
	Polypropylene	<0.1	48
	Polypropylene	<0.52	49
	Polystyrene	<0.25	49
	Polystyrene (white)	<0.1	49
	Bromobutyl rubber	<0.1	24
	Prefilled syringe, barrel, and plunger	<1	24
Vanadium (V)^¹	Type 1 glass	<0.1	24
	Colored glass	19	57
	Polyethylene terephthalate	<0.002	49
	Polyethylene terephthalate	<0.1	49
	Polyethylene terephthalate	<1	28
	Polyethylene terephthalate	<0.01	29
	Low-density polyethylene	<0.002	49
	High-density polyethylene	<0.001	49
	Polyethylene	0.03	29
	Polyethylene (5 samples)	0.002–0.44	60
	Polypropylene	<0.002	49
	Polypropylene (5 samples)	<0.007	60
	Polystyrene	<0.001	49
	Polystyrene (white)	<0.1	49
	Bromobutyl rubber	1.3	24
	Prefilled syringe, barrel, and plunger	3	24

Note:
↵1 Other studies included these elements as targets. Although these studies reported that these elements were not detected by the methodology, insufficient information was provided to assign a detection limit.