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Table 11. LOQ Total Analysis

Choline

Day/

Fortification

Innate Marginal Recovery

MEAN

SD

RSD

r

Replicate

(mg/100g)

(mg/100g)

(%)

(%)

(%)

(%)

1/1

1.5

0.651

101.7

102.6

1.2

1.2

1/2

1.5

0.651

103.4

2/1

1.5

0.651

97.0

97.0

0.0

0.0

2/2

1.5

0.651

97.0

3/1

1.5

0.651

96.2

97.5

1.8

1.8

3/2

1.5

0.651

98.7

MEAN

99.0

Overall RSD

r

1.3

Carnitine

Day/

Fortification

Innate Marginal Recovery

MEAN

SD

RSD

r

Replicate

(mg/100g)

(mg/100g)

(%)

(%)

(%)

(%)

1/1

0.16

<LOQ

104.0

106.2

3.1

2.9

1/2

0.16

<LOQ

108.4

2/1

0.16

<LOQ

103.9

103.3

0.8

0.8

2/2

0.16

<LOQ

102.7

3/1

0.16

<LOQ

97.9

95.4

3.5

3.7

3/2

0.16

<LOQ

92.9

MEAN

101.6

Overall RSD

r

2.8

Repeatability

The repeatability RSD

r

of the method was obtained through analysis of all 17 SPIFAN

test kit materials over at least four days in triplicate. Powders were reconstituted fresh for

each analysis. The working standard levels were prepared fresh each analysis. Each

sample was analyzed by at least two different analysts, with a total of four different

analysts used to generate the precision and accuracy data. Two different instruments and

two different column lots were used. Results that calculated to be outliers based on a

95% confidence interval using Grubb’s outlier test were replaced with re-analysis to

obtain 12 data points overall for each product. Repeatability for the lower level of the

analytical range can be found in the LOQ tests in Tables 10 and 11 and the upper level of

the analytical range in Table 16 for choline due to the absence of products with this high

of an amount. Overall summary tables are provided that give the repeatability of the

method over the analytical range (Tables 12-15). The results obtained meet the

requirements of the SMPR for total choline and carnitine.

Chol-08/Carn-07 (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE