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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 4/22

Appendix D

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

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 were obtained with robust statistics.

For each analyte/matrix pair, the repeatability was compared with the corresponding performance requirement. 93% of the values are within the

requirements (green) and 5% outside (red). 2% could not be attributed (blank values for taurine).

AMINO-01 (FEBRUARY 2017) - APPENDICES

FOR ERP USE ONLY

DO NOT DISTRIBUTE