TABLE I (C)

Total Amounts of Elemental Impurities in Materials (Digestion or Total Pool)

Type of MaterialAmount of Metal in the Material (mg/kg unless noted)Ref.
AgAuIrMoOsPdPtSeTlV
Acrylonitrile-butadiene-styrene19NR1NRNRNRNRNRNRNRNRNR43
Acrylonitrile-butadiene-styreneNRNRNRNRNRNRNRNRNRNR13, 14
CardboardNRNRNRNRNRNRNRNRNRNR31
Cardboard + PE filmNRNRNRNRNRNRNRNRNRNR31
Paper (3 samples)NRNRNRNRNRNRNRNRNRNR33
Paperboard (3 samples)NRNRNRNRNRNRNRNRNRNR33
Type 1 glass vial10<0.1<0.10.24.8NR1.60.50.10<0.10<0.1024
Colorless glass282.4NR0.0516NR24NR1.5NR1957
Polyster bottleNRNRNRNRNRNRNRNRNRNR24
Polycarbonate bottleNRNRNRNRNRNRNRNRNRNR24
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR13, 14
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR13, 14
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR13, 14
Polyethylene terephthalate8NRNRNRNRNRNRNRNRNRNR21
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR27
Polyethylene terephthalate15NRNRNRNRNRNRNRNRNR<128
Polyethylene terephthalateNRNRNRNRNRNRNRNRNR<0.0129
Polyethylene terephthalateNRNRNRNRNRNRNRNRNRNR31
Polyethylene terephthalate19NRNRNRNRNRNRNRNRNRNR43
Polyethylene terephthalate20NRNRNRNRNRNRNRNRNRNR47
Polyethylene terephtalate21<0.19<0.004<0.008<0.93<0.34<0.33<1.1<2.7NR<0.00249
Clear PET bottle26<0.1<0.1<0.1<0.1<0.1<0.1<0.1<0.1NR<0.149
Low-density polyethyleneNRNRNRNRNRNRNRNRNRNR13, 14
Low-density polyethylene4NRNRNRNRNRNRNRNRNRNR21
Low-density polyethylene14NRNRNR<0.36NRNRNRNR<0.10NR26
Low-density polyethylene19NRNRNRNRNRNRNRNRNRNR43
Low-density polyethylene22<0.005<0.002<0.001<0.11<0.034<0.03<0.12<0.2NR<0.00249
PolyethyleneNRNRNRNRNRNRNRNRNR0.0329
PolyethyleneNRNRNRNRNRNRNRNRNRNR31
Polyethylene standard3NRNRNRNRNRNRNRNRNRNR20
PolyethyleneNRNRNRNRNRNRNRNRNRNR27
Polyethylene (5 samples)NR<0.001NRNRNRNRNRNRNR0.002–0.4460
PolyethyleneNRNRNRNRNRNRNRNRNRNR61
High-density polyethyleneNRNRNRNRNRNRNRNRNRNR13, 14
High-density polyethyleneNRNRNRNRNRNRNRNRNRNR13, 14
High-density polyethyleneNRNRNRNRNRNRNRNRNRNR31
High-density polyethylene5NRNRNRNRNRNRNRNRNRNR21
High-density polyethylene bottle12NRNRNRNRNRNRNRNRNRNR24
High-density polyethylene14NRNRNR<0.36NRNRNRNR0.24NR26
High-density polyethylene14NRNRNR<0.36NRNRNRNR<0.10NR26
High-density polyethylene19NRNRNRNRNRNRNRNRNRNR43
High-density polyethylene23<0.012<0.001<0.001<0.12<0.029<0.032<0.11<0.2NR<0.00149
PE/PP blend14NRNRNR2.1NRNRNRNR<0.10NR26
PE/PET/PE laminateNRNRNRNRNRNRNRNRNRNR48
PolypropyleneNRNRNRNRNRNRNRNRNRNR13, 14
PolypropyleneNRNRNRNRNRNRNRNRNRNR13, 14
Polypropylene6NRNRNRNRNRNRNRNRNRNR21
PolypropyleneNRNRNRNRNRNRNRNRNRNR27
PolypropyleneNRNRNRNRNRNRNRNRNRNR31
Polypropylene19NRNRNRNRNRNRNRNRNRNR43
Polypropylene (5 samples)NR<0.001–0.18NRNRNRNRNRNRNR<0.00760
Polypropylene<0.1NRNR<0.1NRNRNR<0.1<0.1<0.148
Polypropylene25<0.039<0.001<0.001<0.10<0.069<0.056<0.08<0.52NR<0.00249
PolystyreneNRNRNRNRNRNRNRNRNRNR13, 14
PolystyreneNRNRNRNRNRNRNRNRNRNR13, 14
Polystyrene (white)NRNRNRNRNRNRNRNRNRNR13, 14
Polystyrene7NRNRNRNRNRNRNRNRNRNR21
PolystyreneNRNRNRNRNRNRNRNRNRNR27
PolystyreneNRNRNRNRNRNRNRNRNRNR31
Polystyrene19NRNRNRNRNRNRNRNRNRNR43
Polysytrene24<0.012<0.001<0.001<0.13<0.06<0.034<0.3<0.25NR<0.00149
White polystyrene27<0.1<0.1<0.1<0.1<0.1<0.1<0.1<0.1NR<0.149
PolymethylmethacrylateNRNRNRNRNRNRNRNRNRNR13, 14
Polymethylmethacrylate9NRNRNRNRNRNRNRNRNRNR21
Polymethylmethacrylate19NRNRNRNRNRNRNRNRNRNR43
Polytetrafluoroethylene16<0.01NRNRNRNRNRNRNRNRNR32
Polytetrafluoroethylene17<0.01NRNRNRNRNRNRNRNRNR32
Polytetrafluoroethylene18<0.01NRNRNRNRNRNRNRNRNR32
Chlorobutyl rubberNRNRNRNRNRNRNRNRNRNR13, 14
Chlorobutyl rubber2NRNRNRNRNRNRNRNRNRNR15
Chlorobutyl rubberNRNRNRNRNRNRNRNRNRNR42
Bromobutyl rubber11<0.1<0.1<0.1<0.1NR<0.1<0.1<0.1<0.11.324
Laminated polyolefinNRNRNRNRNRNRNRNRNRNR13, 14
Laminated polyolefinNRNRNRNRNRNRNRNRNRNR13, 14
Multi-layer polyolefinNRNRNRNRNRNRNRNRNRNR31
Multi-layer polyolefinNRNRNRNRNRNRNRNRNRNR31
Prefilled syringe13<0.5<0.5<0.5<0.5NR<0.5<0.5<1<1324
Polyvinyl chloride (2 samples)NRNR80, 112NRNRNRNRNRNRNR58
Polyvinyl chlorideNRNR65NRNRNRNRNRNRNR59

  • Notes for Tables I (A) through I (C):

  • ↵1 NR = Not reported because this element was not targeted in the analysis. If an element was targeted but not present in measurable quantities, its result is reported as “<x”, where x is the approximate reporting limit.

  • ↵2 Several materials were tested via a nitric acid digestion. The Al was attributed to clay in the formulation used as a reinforcing agent.

  • ↵3 Two materials prepared as reference standards. Sources of these elements were not intentionally spiked into the PE material.

  • ↵4 Five samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵5 Seven samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵6 Four samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵7 Seven samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵8 Two samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵9 Three samples tested. The analysis included 69 elements. Only those elements detected above a detection limit of approximately 0.1 mg/kg were reported.

  • ↵10 Other elements analyzed for but reported as less than 0.1 mg/kg included Be, Cs, Dy, Er, Eu, Gd, Ho, In, Li, Lu, P, Re, Rh, Ru, Sc, Sm, Sn, Ta, Te, Tm. Other elements and their reported levels in in milligrams per kilogram (mg/kg) (unless noted) included B (5.5%), Bi (0.1), Ce (8.8), Ga (1.2), Ge (0.5), Hf (6.0), K (0.1%), La (2.5), Na (2.4%), Nb (0.4), Nd (0.4), Pr (0.5), Sr (1.7), Tb (0.2), Th (0.2), U (0.3), W (0.1), Y (2.8), and Yb (0.1).

  • ↵11 Other elements analyzed for but reported as less than 0.1 mg/kg included Be, Bi, Ce, Cs, Eu, Ge, Hf, Ho, In, Lu, Nb, Re, Rh, Ru, Sc, Ta, Tb, Te, Tm, W, Yb. Other elements and their reported levels in milligrams per kilogram (mg/kg) included B (1.7), Dy (0.4), Er (0.2), Ga (0.1), Gd (0.4), K (117), La (2.0), Li (0.7), Na (87), Nd (1.7), P (43), Pr (0.4), Sm (0.3), Sn (0.7), Sr (25), Th (0.2), U (0.1), and Y (1.0).

  • ↵12 This material contained TiO2 as a filler. Sn was also reported at <5 mg/kg.

  • ↵13 The barrel and plunger tip, consisting of unspecified materials, was digested. Other elements reported and their reported levels in mg/kg included Ga (1), K (24), Na (39), P (10), and Sr (1).

  • ↵14 Additional elements reported and their reported levels in milligrams per kilogram (mg/kg) included U (<0.08).

  • ↵15 Other elements analyzed for but reported as less than 1 mg/kg included Eu, K, Nd, Sc, Th. Other elements and their reported levels in milligrams per kilogram (mg/kg) included B (32) andNa (3.2).

  • ↵16 Other elements reported and their reported levels included K (5.4 mg/kg).

  • ↵17 Other elements reported and their reported levels included K (0.59 mg/kg).

  • ↵18 Other elements reported and their reported levels included K (6.4 mg/kg).

  • ↵19 Multiple materials were characterized: low-density polyethylene = 5 materials; high-density polyethylene = 7 materials; PP = 4 materials; PS = 7 materials; PET = 2 materials; PMMA = 3 materials; and ABS = 1 material.

  • ↵20 Tested 17 PET bottles used to package soft drinks. Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Cl (9–122), K (2 –128), P (141–1365), and S (6–125).

  • ↵21 Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Br (0.50), Ce (<0.44), Cl (<0.11), Cs (<0.16), Dy (<0.008), Er (<0.8), Eu (<0.001), Ga (<0.03), Gd (<0.7), Hf (<0.15), Ho (<0.01), I (<0.026), In (0.05), K (<2.2), La (<0.06), Lu (<0.02), Na (10), Nb (<3.6), Nd (1.3), Pr (<0.12), Rb (<0.66), Re (<0.12), Rh (<0.009), Ru (<1.2), S (<77), Sc (<0.01), Sm (<0.01), Sn (<1.3), Sr (<1.9), Ta (<0.16), Tb (<0.13), Te (<0.45), Th (<0.18), Tm (<0.25), U (<0.02), W (<0.015), and Yb (<0.13).

  • ↵22 Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Br (<0.008), Ce (<0.07), Cl (1.03), Cs (<0.02), Dy (<0.001), Er (<0.036), Eu (<0.001), Ga (<0.002), Gd (<0.05), Hf (<0.004), Ho (<0.001), I (<0.004), In (<0.001), K (<0.14), La (<0.002), Lu (<0.001), Na (<0.07), Nb (<0.36), Nd (<0.05), Pr (<0.02), Rb (<0.25), Re (<0.01), Rh (<0.001), Ru (<0.08), S (<19), Sc (<0.001), Sm (<0.001), Sn (<0.14), Sr (<0.19), Ta (<0.016), Tb (<0.008), Te (<0.044), Th (<0.01), Tm (<0.03), U (<0.001), W (<0.002), and Yb (<0.004).

  • ↵23 Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Br (<0.007), Ce (<0.05), Cl (0.45), Cs (<0.015), Dy (<0.001), Er (<0.042), Eu (<0.001), Ga (<0.002), Gd (<0.05), Hf (<0.01), Ho (<0.001), I (0.005), In (<0.001), K (<0.31), La (<0.004), Lu (<0.001), Na (0.27), Nb (<0.35), Nd (<0.05), Pr (<0.019), Rb (<0.13), Re (<0.016), Rh (<0.001), Ru (<0.069), S (<15), Sc (<0.001), Sm (<0.001), Sn (<0.15), Sr (<0.16), Ta (<0.013), Tb (<0.007), Te (<0.053), Th (<0.007), Tm (<0.025), U (<0.001), W (<0.004), and Yb (<0.04).

  • ↵24 Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Br (<0.012), Ce (<0.12), Cl (3.44), Cs (<0.038), Dy (<0.001), Er (<0.09), Eu (<0.001), Ga (<0.006), Gd (<0.06), Hf (<0.09), Ho (<0.002), I (<0.004), In (<0.001), K (<0.29), La (<0.003), Lu (<0.003), Na (<0.1), Nb (<0.89), Nd (<0.07), Pr (<0.04), Rb (<0.22), Re (<0.02), Rh (<0.001), Ru (<0.18), S (<18), Sc (<0.004), Sm (<0.002), Sn (<0.19), Sr (<0.24), Ta (<0.023), Tb (<0.014), Te (<0.06), Th (<0.022), Tm (<0.054), U (<0.001), W (<0.005), and Yb (<0.012).

  • ↵25 Other elements reported and their reported levels in milligrams per kilogram (mg/kg) included Br (<0.028), Ce (<0.055), Cl (31), Cs (<0.023), Dy (<0.003), Er (<0.042), Eu (<0.001), Ga (<0.003), Gd (<0.04), Hf (<0.013), Ho (<0.002), I (0.083), In (<0.001), K (<0.33), La (<0.007), Lu (<0.017), Na (2.1), Nb (<1.5), Nd (<0.14), Pr (<0.04), Rb (<0.19), Re (<0.045), Rh (<0.001), Ru (<0.09), S (<23), Sc (<0.002), Sm (<0.001), Sn (<0.34), Sr (<0.38), Ta (<0.014), Tb (<0.009), Te (<0.062), Th (<0.011), Tm (<0.042), U (<0.006), W (<0.005), and Yb (<0.008).

  • ↵26 Other elements that were not detected included Br, Ce, Cs, Dy, Er, Ga, Gd, Ge, Hf, Ho, I, In, La, Lu, Nb, Nd, Pr, Rb, Re, Rh, Ru, Sc, Sm, Sn, Ta, Tb, Te, Th, Tm, U, W, Yb. Elements that were detected and which are reported in levels of milligrams per kilogram (mg/kg) included Cl (1.40), K (<0.56), Na (0.79), S (<85), and Sr (<1.4).

  • ↵27 Other elements that were not detected included Br, Ce, Cs, Dy, Er, Ga, Gd, Ge, Hf, Ho, I, In, La, Lu, Nb, Nd, Pr, Rb, Re, Rh, Ru, Sc, Sm, Sn, Ta, Tb, Te, Th, Tm, U, W, Yb. Elements that were detected and which are reported in levels of milligrams per kilogram (mg/kg) included Cl (2.85), K (1.77), Na (11), S (<99), and Sr (<1.3).

  • ↵28 This sample was not Type 1 glass used in pharmaceutical applications. Elements that were detected and which are reported in levels of milligrams per kilogram (mg/kg) included Br (12), Ga (286), K (0.445), La (2.7), Na (12.7%), Nd (20), Rb (23); Ru (18); Sn (103), Te (84), and W (15).