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

Jaudzems, Lahrichi, and Fuerer

January 2017

page 6/22

Appendix F

: intermediate reproducibility data obtained with the SPIFAN II SLV kit products, color-coded with respect to reproducibility

requirement values.

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

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%

Intermediate reproducibility data were obtained with robust statistics.

For each analyte/matrix pair, the intermediate reproducibility was compared with the corresponding reproducibility requirement. 32% of the

values are within the requirements (green) and 67% outside (red). 2% could not be attributed (blank values for taurine).

AMINO-01 (FEBRUARY 2017) - APPENDICES

FOR ERP USE ONLY

DO NOT DISTRIBUTE