Amino-01 (July 2018)

Amino-01 (JULY 2018) 180124 AA SPIFAN SLV Appendix J

FOR ERP USE ONLY DO NOT DISTRIBUTE

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

Sample:

Original validation

% Gain or loss adding in nitrogen sparge prior to hydrolysis

8 Infant Formula Powder Partially Hydrolyzed Soy Based

Sparged with nitrogen trial 1

Sparged with nitrogen trial 2

result not sparged

%Recovery

%Recovery %Recovery

%Recovery %Recovery

avg.ofdups (mg/100g)

avg.ofdups (mg/100g)

avg.ofdups (mg/100g)

AMINO ACIDS

…or negligible difference

Spike 1

Spike 1

Spike 2

Spike 1

Spike 2

0.308

0.346

-12.0

109%

96%

95%

96%

96%

0.346

His

46.582 0.6235

47.789 0.6925 0.8445

-

98% 95% 93% 97%

-

-

-

-

47.789 0.6925 0.8445

Tau Ser Arg Gly Asp Glu Thr Ala Pro Lys Tyr Cys Met Val

0.2 2.5

98% 94% 97% 96% 93% 97% 96% 91% 94% 92% 95% 96% 96% 97% 100% -

98% 95% 95% 98% 93% 93% 95% 95% 94% 94% 92% 92% 94% 94% 95% -

91% 97% 98%

95% 96% 98%

0.897 0.516

0.511 1.577 2.506

-0.1 -7.2 -4.6 -4.5 -3.5 -2.4 -7.9

0.511 1.577 2.506

1.4485

108% 102%

103% 100%

103% 100%

2.378 0.467

0.4705

96%

90% 99% 98%

91%

0.4705

0.5305 0.6295 0.7635

0.551

101%

100%

0.551

0.6395

99%

98%

0.6395

0.844

102%

103%

106%

0.844

0.462

0.4455

0.4

94%

95%

95%

0.4455

0.145

-

-

-

-

100%

0.145

6.0

0.327

0.31

88% 98% 98% 99% 96%

95% 98% 98% 98% 99%

95% 98% 98% 99% 99%

0.31

0.6085

0.461

-2.6 -1.5 -2.0

0.461

0.4505

0.609 0.981 0.648

0.4505

Ile

0.955

0.955

Leu Phe

0.6095

1.6

0.6095

% Gain or loss adding in nitrogen sparge prior to hydrolysis

Sample:

Original validation result not sparged

Sparged with nitrogen trial 1

Sparged with nitrogen trial 2

11 Adult Nut Formula low fat

%Recovery

%Recovery %Recovery

%Recovery %Recovery

avg.ofdups (mg/100g)

avg.ofdups (mg/100g)

AMINO ACIDS

…or negligible difference

Spike 1

Spike 1

Spike 2

Spike 1

Spike 2

0.384

1.6

95% 96% 93% 94% 98% 95% 98% 94% 97% 94% 90% 95% 96% 96% 96% 104% 100% 102%

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

96%

97%

0.388

His

-

-

-

-

NQ

Tau Ser Arg Gly Asp Glu Thr Ala Pro Lys Tyr Cys Met Val

-0.5

0.64

92% 96% 98%

93% 97% 99% 97% 96% 99% 98% 102% 103%

0.6225 0.7625

0.817 1.373 1.299 2.252 0.604 0.805 1.166 0.911 0.618 0.345 0.919 0.809 1.246 0.697 -

3.3 0.9

1.32

-0.8 -2.4 -0.4

105%

1.285

98% 93%

2.1585 0.6015 0.7815

1.3 3.5 5.2 2.0 5.6 2.2 1.3 1.4 2.0 -

100%

97%

1.109

102%

0.8265

95%

96%

0.603

-

-

0.1545

95% 98% 98% 98% 98%

96% 97% 97% 98% 98%

0.331 0.863

0.7455 1.2015 0.6795

Ile

Leu Phe

% Gain or loss adding in nitrogen sparge prior to hydrolysis

Sample:

Original validation result not sparged

Sparged with nitrogen trial 1

Sparged with nitrogen trial 2

16 Infant Form PWD soy based

%Recovery

%Recovery %Recovery

%Recovery %Recovery

avg.ofdups (mg/100g)

avg.ofdups (mg/100g)

AMINO ACIDS

…or negligible difference

Spike 1

Spike 1

Spike 2

Spike 1

Spike 2

0.31

-0.4 0.7 3.3 2.0 0.8 1.1 2.6 1.8 2.0 0.3 4.1 2.3 -0.1 -1.1 -0.9 -0.8

97% 98% 96% 97% 98%

97% 99% 92% 99% 99%

96% 98%

0.3135 58.3415 0.7185

His

55.774

Tau Ser Arg Gly Asp Glu Thr Ala Pro Lys Tyr Cys Met Val

0.57

107%

0.941 0.546 1.577

99% 99%

0.925

0.5375

105%

105% 101%

104% 100%

1.537 2.505 0.492

2.56 0.44

99% 93%

97% 99% 97%

98%

0.567 0.664

102% 100% 104%

101%

0.5505 0.6515

99%

0.83

105%

102%

0.823 0.478

0.473 0.161 0.375 0.695

97%

98%

97%

100%

102%

106%

0.1535

94% 97% 98% 98% 98%

96% 98% 98%

96% 95% 95% 99%

0.376

0.5905 0.5895 1.0165 0.6725

0.69

Ile

1.041

1.4 2.1

100% 100%

Leu Phe

0.69

100%

Jaudzems, Guthrie, Lahrichi, and Fuerer – January 2018

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