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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 17/20
9 Toddler Formula Powder Milk-Based
4.6
Results
Average concentrations expressed in mg/100 g reconstituted product are detailed below for
each analyte/matrix pair and are presented in their full-sized version in Appendix A. Values
are based on robust statistics. Appendix B contains the same values converted to mg/100 g
product. Values are identical between Appendix A and Appendix B for ready-to-feed (RTF)
products (3, 4, 5, 17, 18, 19).
Average values of the SPIFAN II SLV kit products in mg/100 g reconstituted product.
The color code indicates the category according to the SMPR: 0.4-5.0 (red), 5.0-50 (orange),
and 50-2500 (green) mg/100 g reconstituted product).
4.7
Repeatability
Appendix C details the repeatability requirements for each analyte/matrix pair according to
the analyte concentrations listed in Appendix A. Repeatability results (based on robust
statistics) are detailed below for overview and are presented in their full-sized version in
Appendix D.
Repeatability data, color-coded with respect to performance requirement values.
From the table above (and Appendix D), 93% of the values are within the requirements and 5%
outside. 2% could not be attributed (blank values for taurine).
Analyte 1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16 17 18 19
His
41.2 45.3
126.5 195.8
27.0 34.6 22.2 31.9 35.5 27.2 44.9 37.9 44.2 28.0 25.6 33.6 28.0
129.0 189.0
Tau N/A N/A N/A N/A N/A
4.1 4.7
5.2
3.5 4.7
N/A
8.1
4.0 3.8 4.7
6.4
4.7
17.5 20.1
Ser
98.2 62.3 307.8 448.8 82.3 78.4 71.6 73.3 87.5 65.9 71.0 88.9 57.9 66.8 66.3 75.2 79.3 312.0 461.8
Arg
63.6 105.4 709.3 244.0
35.8 43.3 29.8
94.4
46.3 35.2
87.2 59.3 103.8
36.8 34.1
100.7
36.0
707.5 237.0
Gly
36.3 47.3
106.0 141.8
28.0 27.0 24.7
56.5
29.9 26.6
153.3
35.4 48.8 25.2 22.5
58.3
28.0
106.3 141.0
Asp
158.1 198.1 503.0 581.3 155.8 126.2 159.4 173.4 147.9 121.4 143.5 147.1 195.9 127.3 113.9 173.5 145.8 491.8 583.3
Glu
363.5 244.0 1237.8 1789.0 302.5 305.4 241.5 279.1 334.3 209.8 243.4 334.9 239.9 248.5 244.4 281.4 287.8 1205.8 1785.5
Thr
79.6 79.7 252.5 326.5 87.0 70.3 93.1 52.8 79.1 61.1 69.5 75.4 78.9 65.7 66.3 54.0 85.8 252.8 328.5
Ala
64.3 64.6 218.8 240.8 65.3 52.2 69.5 61.9 61.3
40.6
89.5 60.4 62.5 53.1
49.7
61.5 62.3 214.8 239.5
Pro
146.4 61.4 519.0 840.5 116.3 129.8 77.6 70.4 134.7 79.0 129.2 136.2 60.8 93.1 97.0 72.1 113.5 510.8 835.8
Lys
143.4 119.8 491.0 594.8 121.0 120.8 131.6 89.3 141.4 100.4 98.0 132.0 111.6 112.6 100.2 87.5 115.5 484.8 597.8
Tyr
75.6 93.2 267.5 398.0 55.8 64.3
37.1 49.7
68.7 57.3 69.1 72.1 95.6 52.7
49.9
52.4 56.3 271.3 403.0
xCys
17.7 22.4
59.3
26.9 23.3 14.6 33.5 16.4 20.4 24.9 16.8 17.6 23.9 23.5 18.4 16.1 22.8
56.5
25.3
Met
38.1 41.3
138.8 196.3
31.5
51.0
25.6 34.1 36.6 22.3 37.3 36.0 43.0 29.6 28.6 41.4 32.0
141.5 199.5
Val
96.9 141.4 326.0 489.4 81.8 90.8 69.0 56.5 88.9 64.9 98.4 90.7 142.5 74.1 68.8 62.3 88.3 324.0 477.8
Ile
84.6 122.8 274.3 380.9 76.8 79.7 74.4 56.0 78.5 59.2 86.8 80.5 124.6 68.8 63.4 62.6 84.8 270.0 372.3
Leu
164.6 203.3 584.3 724.8 150.3 139.9 138.3 109.0 157.5 111.6 140.6 155.5 200.7 133.3 120.6 111.3 148.8 574.5 723.0
Phe
79.2 103.1 258.8 397.3 59.3 65.5
42.0
69.0 68.9
49.4
78.0 75.5 104.9 54.7 51.1 74.1 58.8 260.5 388.3
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
His
0.7% 0.4% 1.2%
3.7%
1.9% 0.5% 0.8% 0.9% 2.0% 1.1% 1.4% 1.2% 3.0% 1.2% 2.0% 1.4% 0.0% 1.6% 0.8%
Tau N/A N/A N/A N/A N/A
1.2% 1.4% 1.8% 2.3% 1.3%
N/A
1.0% 1.9% 1.7% 2.8% 1.8% 1.6% 2.2% 2.5%
Ser
0.7% 0.6% 0.2% 0.7% 0.6% 1.0% 1.0% 0.7% 1.0% 0.8% 0.4% 0.8%
2.9%
1.9% 2.0% 0.5% 0.7% 1.5% 1.5%
Arg
0.5% 0.4% 0.8% 1.9% 1.5% 1.3% 1.4% 1.1% 1.5% 1.3% 1.9% 1.6% 1.7% 1.7% 1.2% 1.3% 1.5% 1.6% 2.0%
Gly
0.6% 1.1% 1.0% 1.7% 1.9% 0.4% 1.2% 1.2% 1.4% 0.4% 1.0% 1.0% 1.2% 0.7% 0.5% 0.5% 0.0% 1.0% 1.5%
Asp
0.9% 1.5% 1.4%
2.3%
0.7% 0.5% 0.4% 0.7% 0.8% 1.2% 0.9% 0.4% 1.7% 0.6% 1.8% 0.5% 0.7% 0.6% 1.1%
Glu
0.6% 0.6% 0.6% 2.0% 1.0% 0.5% 0.3% 0.8% 0.6% 0.7% 0.5% 0.6% 1.4% 0.4% 0.5% 0.7% 0.5% 0.6% 1.6%
Thr
0.3% 0.6% 0.4% 0.6% 0.6% 0.7% 0.8% 0.7% 0.7% 1.1% 0.4% 0.5% 1.6% 1.2% 1.3% 0.4% 0.6% 1.0% 1.3%
Ala
0.5% 0.9% 1.2% 1.7% 0.8% 0.7% 0.3% 0.8% 0.7% 0.7% 0.4% 0.5% 1.6% 0.4% 0.5% 0.3% 0.8% 0.7% 1.3%
Pro
0.4% 0.3% 0.5% 1.4% 0.9% 0.8% 0.5% 1.3% 0.6% 0.7% 0.8% 0.4% 1.2% 0.6% 0.7% 0.4% 0.0% 0.8% 1.0%
Lys
1.0% 0.6% 0.5%
3.0%
0.9% 1.0% 0.7% 1.4% 1.2% 0.5% 1.0% 1.3% 1.9% 0.9% 0.9% 0.7% 0.9% 0.9% 1.5%
Tyr
0.5% 1.6% 1.6% 1.8% 0.9% 0.8% 0.6% 1.5% 1.5% 1.7% 1.3% 0.6%
2.4%
0.3% 1.0% 1.3% 1.9% 1.2% 1.0%
xCys
1.0% 0.5% 0.9%
3.1%
0.0% 1.6% 1.2% 1.4% 1.1% 2.1% 1.7% 1.3%
3.9%
0.7% 0.6% 2.9% 0.0% 0.0% 2.1%
Met
0.3% 0.7% 0.8% 1.6% 1.7% 1.5% 1.4% 1.0% 1.1% 1.0% 1.1% 1.3% 0.7% 0.8% 0.6% 1.0% 0.0% 1.5%
2.1%
Val
2.0% 0.3% 1.1% 1.5%
2.6%
0.8% 1.2% 1.3% 2.0% 1.7% 0.7% 0.8% 0.9% 1.8% 1.6%
3.4%
1.8% 1.9% 1.1%
Ile
1.7% 0.3% 1.3% 1.9%
3.4%
0.9% 0.7% 1.1%
2.2% 2.1%
0.7% 0.8% 1.2%
2.2% 2.3% 3.2% 2.5% 2.3%
1.7%
Leu
0.5% 0.3% 0.5% 1.4% 1.0% 0.9% 0.5% 0.7% 1.2% 0.5% 0.5% 0.5% 1.0% 0.6% 0.7% 0.9% 0.4% 0.8% 1.0%
Phe
0.7% 0.7% 1.2% 2.0% 1.8% 0.6% 1.1% 1.0% 1.9% 1.1% 0.8% 1.1% 1.2% 0.5% 1.1% 0.7% 1.8% 0.8% 0.9%
SPIFAN II SLV kit product
AMINO-01 (FEBRUARY 2017)
SLV REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE