OMB Meeting Book_9-11-14
Table 20: Reproducibility data for hydrolysate-based infant formula test sample
Sample ID: Sample 3 X-8281/D-5352 Analyte CMP
UMP
GMP
IMP
AMP
(mg hg -1 )
(mg hg -1 )
(mg hg -1 )
(mg hg -1 )
(mg hg -1 )
Laboratory
Rep-1
Rep-2
Rep-1
Rep-2
Rep-1
Rep-2
Rep-1
Rep-2
Rep-1
Rep-2
1 2
9.61
9.63
4.30 4.00
4.22 3.70
1.33 1.40
1.35 1.40
2.32 2.50 2.46 2.95 a
2.34 2.50 2.44 3.90 a
4.96 5.10
4.95 4.70
10.30
10.10
3
9.60
9.53
3.59
3.38
1.60
1.58
4.79
4.76
4
10.70
10.90
4.40
4.40
1.40
1.40
5.10
5.20
5
10.91
10.20
4.11
4.31
1.44
1.33
2.52
2.54
4.88
4.89
6
10.23
10.21
4.56
4.51
1.48 1.25 b
1.39 1.04 b
2.37 2.40 b
2.35 2.21 b
4.75 4.57 b
4.72 3.84 b
7
9.49
8.56
4.25
4.47
8
8.93
9.19
3.63
3.58
1.33
1.34
2.38
2.42
4.32
4.51
9
9.96
9.96
4.33
4.28
1.41
1.40
2.39
2.41
4.67
4.65
10
9.83
9.98
4.51
4.11
1.36
1.41
2.38
2.43
4.79
5.01
11
10.30
10.10
4.00
3.70
1.40
1.40
2.50
2.50
5.10
4.70
12
9.03
9.09
4.53
4.60
1.39
1.38
2.78
2.74
4.79
4.77
a Identified as Cochran outlier; results removed from data set for statistical analysis b Identified as Cochran outlier; results kept in data set for statistical analysis
Table 21: Reproducibility analysis for hydrolysate-based infant formula test sample
Sample ID: Sample 3 X-8281/D-5352
CMP
UMP
GMP
IMP
AMP
Analyte Symbol
Seq.
Item
Value
Value
Value
Value
Value
11 a
1 2
Total number of laboratories
n
12 24
12 24
12 24
12 24
Total number of replicates
2n
22
3
Overall mean of all data (grand mean)
9.72
4.15
1.38
2.46
4.73
4
Repeatability standard deviation
S r
0.26
0.13
0.05
0.04
0.19
5
Reproducibility standard deviation
S R
0.69
0.36
0.11
0.13
0.30
6
Repeatability limit in SMPR
≤6%
≤6%
≤6%
≤6%
≤6%
7
Repeatability relative standard deviation
RSD r
2.7%
3.1%
3.9%
1.8%
3.9%
8
Reproducibility limit in SMPR
≤11%
≤11%
≤11%
≤11%
≤11%
9
Reproducibility relative standard deviation
RSD R
7.1%
8.7%
7.7%
5.5%
6.2%
10
HorRat value
0.9
1.0
0.7
0.6
0.7
a Less than 2/9 laboratories removed from statistical analysis.
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