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Single Laboratory Validation Report for Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals
Jaudzems, Lahrichi, and Fuerer
–
January 2017
page 18/20
4.8
Intermediate reproducibility
Appendix E details the reproducibility requirements for each analyte/matrix pair according to
the analyte concentrations listed in Appendix A. Intermediate reproducibility results (based
on robust statistics) are detailed below for overview and are presented in their full-sized
version in Appendix F.
Intermediate reproducibility data, color-coded with respect to reproducibility requirement values.
From the table above (and Appendix F), 32% of the values are within the requirements and
67% outside. 2% could not be attributed (blank values for taurine).
4.9
Recovery
Appendix G details the recovery requirements for each analyte/matrix pair according to the
analyte concentrations listed in Appendix A. Spike recovery results (based on robust
statistics) are detailed below for overview and are presented in their full-sized version in
Appendix H.
Recovery data, color-coded with respect to performance requirement values.
From the table above (and Appendix H), 77% of the values are within the requirements and
23% outside.
The last column is the average recovery value for each amino acid across all the SLV kit.
Those values are between 95% and 105% except for two amino acids: aspartic acid shows a
bias towards high recovery (106.9% on average), and methionine shows a bias towards low
recovery (92.5%).
Analyte 1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17 18 19
His
4.9% 7.8% 4.6% 11.0% 6.8% 4.7% 7.5% 10.0% 9.2% 5.6% 7.6% 6.4%
3.7%
6.3% 12.0% 7.5% 4.3% 7.5% 9.3%
Tau N/A N/A N/A N/A N/A
2.3% 4.2%
4.2% 10.2%
2.2%
N/A
6.3% 7.1%
3.7%
7.7% 6.6% 6.2%
3.9%
4.4%
Ser
7.4% 10.6% 6.9% 5.7% 5.8% 9.0% 4.2% 6.7%
2.3% 2.4%
3.5% 7.4% 6.3%
3.0%
5.0% 7.9% 5.3% 8.8% 9.7%
Arg
3.7%
2.1% 2.0%
7.9% 7.6%
2.7%
6.4%
3.0%
8.1% 6.4% 5.1% 8.2% 4.3% 6.4% 8.0% 8.1%
2.0%
6.6% 7.2%
Gly
3.0% 3.9% 2.6%
5.5%
2.5% 1.0% 1.9%
3.2% 4.3% 5.0% 5.0% 7.2% 6.4%
3.7%
4.1% 9.4%
0.0%
6.2% 6.0%
Asp
2.0%
3.4%
1.7% 2.1%
4.2% 3.3% 4.2% 4.7% 4.3% 3.3%
1.1%
4.3%
2.3% 1.2%
6.8% 5.2% 3.9%
1.8%
3.8%
Glu
1.4%
3.7%
1.7% 2.0%
3.2%
1.2%
3.8% 3.6%
3.0% 2.9% 2.2%
4.4% 3.5% 3.2% 5.6% 5.1% 3.1%
1.5%
4.5%
Thr
3.1%
2.1% 2.6%
3.9% 3.1%
2.7% 1.3% 1.6%
3.6%
1.9% 0.8%
4.8%
2.8% 0.9% 2.6%
5.4%
2.5%
4.9% 5.1%
Ala
2.0% 1.3%
3.5% 3.4% 3.7%
1.3%
4.3% 4.3% 3.5%
2.7% 1.9%
5.3% 4.0%
2.3%
4.6% 4.5%
2.5%
4.2% 5.6%
Pro
0.6% 2.8% 1.8% 2.4% 1.9% 1.1% 1.4%
3.2% 4.2% 3.2%
3.0%
4.0%
2.3% 2.7%
3.8% 5.5%
2.1%
4.6% 5.3%
Lys
1.4%
3.2%
1.6% 2.8%
3.5%
3.0%
7.4% 10.2%
2.3%
3.9% 3.9% 3.4% 3.9% 4.9% 11.3% 8.9% 6.2% 5.1% 3.1%
Tyr
4.3% 5.5%
2.5%
6.2% 3.8%
2.9%
5.2% 5.7% 5.8%
2.5%
6.1% 4.3% 3.7%
1.8%
7.1% 9.2% 4.4% 4.9% 7.4%
xCys
4.2% 10.6% 5.1%
3.8%
5.1%
3.4% 3.9%
5.4% 6.5%
2.4% 3.4% 3.5%
10.5%
3.7%
8.1% 8.1% 5.2%
2.6%
6.1%
Met
5.7%
3.4% 1.4%
9.1% 7.7%
2.3% 2.1%
4.1% 4.1%
1.9% 1.8% 1.4% 3.3% 2.5% 4.0%
6.3%
1.9%
6.8% 7.2%
Val
10.0%
0.8%
9.4% 5.5% 13.3% 6.7% 9.4% 20.7% 13.9% 7.4% 4.3% 11.9%
2.5%
6.1% 12.8% 15.0% 6.5% 11.4% 12.2%
Ile
10.2%
0.5%
9.6% 8.3% 15.7% 8.6% 10.8% 22.4% 14.5% 8.8% 7.9% 13.7% 3.5% 8.0% 13.7% 14.1% 6.2% 11.8% 12.1%
Leu
1.8%
3.7%
2.4% 2.3% 1.8% 1.3% 2.7% 2.8%
5.2% 4.4% 3.4%
0.9%
3.1%
2.3%
6.2% 7.9%
1.8%
4.3% 7.5%
Phe
5.5% 5.2% 4.0% 5.2% 3.3%
2.5%
8.3% 7.0% 5.5% 6.1% 5.2% 5.5% 5.8% 4.4% 9.4% 8.5% 3.3% 3.7% 5.8%
SPIFAN II SLV kit product
Analyte 1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17 18 19 av
His
98.4% 99.9% 98.6%
90.1%
100.1% 92.6% 99.6%
108.9%
94.8% 103.3% 95.1% 102.1% 96.0% 102.5% 97.9% 97.2% 97.7% 98.7% 97.5%
98.5%
Tau
100.3% 101.0% 99.1%
94.0%
96.0% 97.0% 97.0% 97.9% 96.2% 100.0% 95.9%
109.6%
99.7% 99.2% 98.2% 97.9% 99.2% 100.1% 99.4%
98.8%
Ser
109.5%
103.0% 96.6%
91.4% 79.8%
104.0%
93.2%
95.3% 97.5% 95.0%
93.2%
102.1%
93.0% 94.0%
96.8% 96.4%
91.8%
95.6% 99.1%
96.2%
Arg
96.5% 98.3% 101.4%
90.8%
92.4% 94.8%
91.9% 93.1%
93.2%
91.6% 93.8%
104.4%
90.3%
92.6% 94.5% 97.1% 95.7% 99.5% 95.9%
95.2%
Gly
100.2% 99.4% 100.4%
94.3%
98.4% 97.9% 97.5% 97.0% 97.1% 104.4% 97.5% 107.2% 106.2% 102.3% 97.0% 98.2% 101.2% 99.4% 98.6%
99.7%
Asp
112.7% 110.5%
102.8% 101.1%
108.0% 105.2%
104.9%
108.5% 114.1% 107.4%
104.1%
112.1% 108.5% 108.9% 106.6%
103.6%
105.0%
102.3%
105.5%
106.9%
Glu
106.9%
103.5%
105.5% 94.2%
103.6% 103.4% 98.6% 102.1%
110.4%
103.6% 99.6%
109.7%
103.3% 103.8% 101.1% 100.0% 101.3% 98.7% 98.4%
102.5%
Thr
100.0% 99.2% 98.6%
92.0% 90.5%
99.6%
94.8%
95.7% 97.2% 97.2%
94.8%
104.6% 96.8% 97.2% 96.6% 96.7% 96.1% 97.2% 97.7%
97.0%
Ala
102.2% 102.2% 101.7% 95.7% 99.9% 99.5% 98.0% 101.1% 104.2% 101.5% 98.2%
107.6%
102.1% 101.7% 99.9% 98.9% 100.1% 99.7% 99.3%
100.7%
Pro
101.0% 100.5% 103.5%
93.7%
97.4% 100.2% 95.5% 99.1% 101.4% 99.1%
94.3% 106.3%
98.8% 99.5% 98.4% 97.5% 99.0% 99.3% 97.0%
99.0%
Lys
107.7% 106.2% 106.6%
98.9% 100.5% 100.6% 97.3%
105.8% 112.9%
100.5% 97.1% 104.3% 102.5% 101.9% 102.5% 102.1% 104.3% 104.1% 99.6%
102.9%
Tyr
99.9% 99.9% 98.4%
93.9% 92.8%
96.1% 92.6% 94.1% 95.7% 97.9%
93.5%
102.2% 95.7% 97.3% 96.8% 97.2% 96.8% 99.1% 96.9%
96.7%
xCys
102.0% 102.6% 103.3% 94.0% 96.4% 99.4% 96.6% 99.8% 99.7% 101.3% 102.2% 100.6% 98.7% 100.4% 100.8% 99.9% 101.8% 96.1% 97.2%
99.6%
Met
88.7% 90.1% 94.6% 90.2% 89.6%
95.4%
89.8% 88.2% 90.2%
95.8%
90.2%
102.5% 93.9% 94.9% 92.7% 93.6% 92.7%
93.6% 90.8%
92.5%
Val
94.0%
101.2% 100.5%
85.4%
101.5%
91.6% 94.3%
98.4% 100.0% 98.3% 95.3%
107.9%
100.5% 99.3% 98.1% 97.3% 99.8% 102.8%
93.4%
97.9%
Ile
94.2%
101.0% 99.7%
87.0%
101.3%
89.8% 93.8%
97.7% 98.7% 101.2% 96.1%
107.6%
99.9% 99.6% 97.6% 97.5% 99.5% 102.1%
94.8%
97.9%
Leu
100.2% 101.5% 102.2%
91.4%
98.9% 96.8% 95.8% 98.8% 102.0% 99.6% 96.4%
107.9%
101.5% 100.1% 99.0% 98.3% 99.9% 101.6% 95.7%
99.3%
Phe
99.9% 100.8% 100.3%
93.0%
98.4% 96.8% 96.8% 95.9% 96.4% 100.2% 96.4%
108.2%
102.1% 100.0% 98.8% 98.2% 99.4% 100.8% 97.5%
98.9%
SPIFAN II SLV kit product
AMINO-01 (FEBRUARY 2017)
SLV REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE