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Single Laboratory Validation – AOAC First Action Method 2012.22 Vitamin C in Infant Formula and Adult/Pediatric

Nutritional Formula by UPLC-UV

Date of Issue: February 14

th

, 2013

RDLS-RD130018

E.Campos Giménez (NRC/QS, Lausanne)

Page 7

Single Laboratory Validation,

Continued

LoD/LoQ

Results from 10 independent analysis of a placebo sample spiked at low

concentrations are given below:

Infant Formula RTF, milk based

Average

(mg/100 g)

RSD

Accuracy

Spike level 2.5 mg/100 g

2.47

1 %

99 %

Spike level 1.25 mg/100 g

1.29

1 %

103 %

Spike level 0.5 mg/100 g

0.65

3 %

130 %

Although the precision at 0.5 mg/100 g was still acceptable, the accuracy did not

meet the performance requirements. Thus, the quantification limit was set at

1.25 mg/100 g.

Precision

studies

Results of precision studies are shown below.

Requirements (SMPR)

≤ 5 %

Mean

(mg/100 g)

RSD

r

(%)

RSD

iR

(%)

SRM 1849a

7.0

2.0

4.4

Adult Nutritional Powder Milk Protein Based

5.9

1.0

3.9

Infant Formula Powder Part Hyd Milk Based

13.4

0.9

5.5

Infant Formula Powder Part Hyd Soy Based

19.1

0.9

2.6

Adult Nutritional Powder Low Fat

13.5

1.3

3.1

Child Formula Powder

4.8

0.5

1.0

Infant Elemental Powder

36.8

1.7

1.3

Infant Formula Powder Milk Based

11.8

1.4

1.4

Infant Formula Powder Soy Based

10.6

1.4

2.0

Infant Formula RTF Milk Based

8.0

0.7

4.8

Adult Nutritional RTF High Protein

29.9

0.8

4.2

Adult Nutritional RTF High Fat

39.3

2.5

5.3

RSD

r

is the relative standard deviation of repeatability

RSD

iR

is the relative standard deviation of intermediate reproducibility

Continued on next page

8 / 20

VitC-03/2012.22

For ERP Use Only

DO NOT DISTRIBUTE

AOAC OMB Meeting Book

317