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Application No.J99"
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Table 7 Analytical Results of Eye Drop
*2 Converted
Measured
PDE value for *3 Permitted Post-treatment Spike concentration *1 Spike-and- detection limit (3М)
Element parenteral concentration concentration concentration (Eye drop) recovery rate in ophthalmic
solution
μg μg/mL μg/mL μg/mL μg/mL % μg/mL
As 15 15 3 1 <DL 104 0.04
Cd 2 2 0.4 0.4 <DL 101 0.0006
Hg 3 3 0.6 0.3 <DL 105 0.007
Pb 5 5 1 0.3 <DL 102 0.01
Co 5 5 1 0.3 <DL 95 0.001
Ni 20 20 4 0.5 <DL 104 0.003
V 10 10 2 0.5 <DL 98 0.0008
Ag 10 10 2 0.5 <DL 104 0.0008
Au 100 100 20 0.5 <DL 99 0.006
Ir 10 10 2 0.5 <DL 101 0.01
Os 10 10 2 0.5 <DL 103 0.006
Pd 10 10 2 0.5 <DL 102 0.004
Pt 10 10 2 0.5 <DL 99 0.02
Se 80 80 16 0.5 <DL 103 0.02
Rh 10 10 2 0.5 <DL 95 0.007
Ru 10 10 2 0.5 <DL 103 0.003
Tl 8 8 1.6 0.5 <DL 95 0.02
Ba 700 700 140 0.5 <DL 96 0.0006
Cr 1100 1100 220 0.5 <DL 97 0.002
Cu 300 300 60 0.5 <DL 96 0.002
Li 250 250 50 0.5 <DL 99 0.01
Mo 1500 1500 300 0.5 <DL 100 0.003
Sb 90 90 18 0.5 <DL 103 0.01
Sn 600 600 120 0.5 <DL 100 0.01
PDE value for parenteral
Permitted concentration : When 1 mL of the ophthalmic solution is used per day (Option 3 is used when calculating
the conversion to the PDE concentration)
Post-treatment concentration : The permitted concentration in the measurement sample after pretreatment of the sample
Spike concentration : Concentration of spiking solution in spike-and-recovery testing
Converted detection limit (3М) in ophthalmic solution: Detection limit (3М) in measurement solution × Dilution factor (5)
<DL: Below the detection limit (3М)

Table 8 Analytical Results of Tablet
Measured
*3 Permitted Post-treatment Spike *1 Spike-and- *2 Tablet converted
PDE value for oral concentration
Element concentration concentration concentration (Tablet) recovery rate detection limit (3М
μg μg/g μg/mL μg/mL μg/g % μg/g
As 15 75 1.5 0.5 <DL 107 0.5
Cd 5 25 0.5 0.1 <DL 100 0.007
Hg 30 150 3 1 <DL 101 0.1
Pb 5 25 0.5 0.1 <DL 98 0.07
Co 50 250 5 1 <DL 101 0.01
Ni 200 1000 20 1 0.1 100 0.03
V 100 500 10 1 <DL 103 0.01
Ag 150 750 15 1 <DL 104 0.02
Au 100 500 10 1 <DL 105 0.03
Ir 100 500 10 1 <DL 100 0.09
Os 100 500 10 1 <DL 85 0.04
Pd 100 500 10 1 <DL 106 0.05
Pt 100 500 10 1 <DL 102 0.3
Se 150 750 15 1 <DL 108 0.3
Rh 100 500 10 1 <DL 101 0.1
Ru 100 500 10 1 <DL 100 0.03
Tl 8 40 0.8 0.1 <DL 103 0.2
Ba 1400 7000 140 1 <DL 102 0.003
Cr 11000 55000 1100 1 <DL 101 0.02
Cu 3000 15000 300 1 <DL 105 0.05
Li 550 2750 55 1 <DL 104 0.1
Mo 3000 15000 300 1 <DL 101 0.03
Sb 1200 6000 120 1 <DL 105 0.1
Sn 6000 30000 600 1 <DL 100 0.03
PDE value for oral
Permitted concentration : Permitted concentration in daily intake (0.2 g) (Option 3 is used for calculation of conversion
from PDE to concentration)
Post-treatment concentration : Permitted limit concentration in measurement solution following sample pretreatment
Spike concentration : Concentration of the added spike-and-recovery test solution
Tablet converted detection limit (3М): Detection limit (3М) in measurement solution Dilution factor (50)
<DL: Below the detection limit (3М)
4FDPOE Edition: +VO. 201
First Edition: Sep. 2014

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