Amino-01 (July 2018)

Single Laboratory Validation Report for Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals

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

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 Arg Gly

98.2 62.3 307.8 448.8 63.6 105.4 709.3 244.0

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 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

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

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), 5.0-150 (orange), and 150-2500 (green) mg/100 g reconstituted product).

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.

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%

Repeatability data, color-coded with respect to performance requirement values.

From the table above (and Appendix D), >99.7 of the values are within the requirements and <2% could not be attributed (blank values for taurine).

Jaudzems, Guthrie, Lahrichi, and Fuerer – January 2018

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