SPSFAM ERP
Table AI-2-35 . Tablet Lactose and Isomaltulose Spike Results
%RSD r
%RSD R
Approx. Spiking level (%)
Actual Spiking level (%)
Average Innate level (%)
Measured Result (%)
Total Recovery (%)
Average Recovery n=3 (%)
Average Recovery n=6 (%)
Analyte
Site
Sample ID
n=3
n=6
6891051 6891052 6891053 6594381 6594382 6594385 6891054 6891055 6891056 6594388 6594390 6594393 6891051 6891052 6891053 6594381 6594382 6594385 6891054 6891055 6891056 6594388 6594390 6594393
0.0964 0.0982 0.0961 0.0975 0.0973 0.0977
0.0928 0.0949 0.0899 0.0892 0.0869 0.0882
96.3 96.6 93.5 91.5 89.3 90.3 98.6 98.0 96.7 94.7 96.1 100.0 100.1 101.7 109.4 88.0 90.6 89.7 95.8 95.8 101.4 101.4 99.3
HAR
0
95.5
1.8
0.1
92.9
3.3
MSN
0
90.4
1.2
Lactose
1.47 1.47 1.45 1.52 1.52 1.52
1.45 1.44 1.45 1.47 1.44 1.46
HAR
0
98.9
1.0
1.5
97.4
1.9
MSN
0
95.8
1.1
0.0934 0.0951 0.0932 0.0930 0.0928 0.0932
0.0935 0.0967 0.102 0.0818 0.0841 0.0836
HAR
0
103.7
4.8
0.1
96.6
8.7
89.4
MSN
0
1.5
Isomaltulose
1.43 1.43 1.40 1.45 1.45 1.45
1.37 1.37 1.39 1.47 1.47 1.49
HAR
0
97.0
2.1
1.5
99.4
3.0
MSN
0
101.9
0.8
102.8 Bold indicates individual result outside SMPR criterion Table AI-2-36 . Tablet Maltose Spike Results
Approx. Spiking level (%)
Actual Spiking level (%)
Average Innate level (%)
Measured Result (%)
Average Recovery n=3 (%)
%RSD r n=3
Total Recovery (%)
Analyte
Site
Sample ID
6891051
0.0922
0.193
97.9
0.1
99.5
1.4
6891052
0.0938
0.200
100.6
6891053
0.0919
0.197
100.1
Maltose
HAR
0.105
6891054
1.41
1.46
96.4
1.5
97.5
2.0
6891055
1.41
1.46
96.4
6891056
1.39
1.49
99.7
Table AI-2-37 . Premix Galactose Spike Results Sample ID Approx. Spiking level (%) Spike Level Added (%) Average Innate level (%)
Total Recovery (%)
Mean Recovery n=3 (%)
Measured Result (%)
%RSD r n=3
5907396-1 5907396-2 5907396-3 5907396-4 5907396-5 5907396-6
1.58 1.57 1.58 2.33 2.35 2.38
1.54 1.52 1.53 2.25 2.27 2.27
97.5 96.8 96.8 96.6 96.6 95.4
1.5
97.0
0.4
0.00
2.25
96.2
0.7
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