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Method Validation Report

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Validation Report for the Determination of Thiamin HCl, Riboflavin, Niacin (Nicotinic Acid and Nicotinamide), Pantothenic acid, Vitamin B6 (Pyridoxine, Pyridoxal and Pyridoxamine) and Biotin in Infant Formula and Adult Nutritionals by LC-MS/MS

Document Title

Table 47: Accuracy of Pyridoxamine in Partially hydrolyzed protein infant formula powder

Pyridoxamine (mcg/100g)

Un- spiked Result

Resulting Spiked Conc

Spiked Result

% Recovery

Acceptable

Over Spike

Theoretical Spiked Conc (C)

Replicates

(A)

(B)

(A+C)

B/(A+C)

Y/N

Replicate 1 22.07

Mean

Replicate 2 24.41

23.24

0%

Replicate 3 23.24

Replicate 1

39.59

38.24

15.00

103.54

Y

Replicate 2

38.45

38.24

15.00

100.54

Y

60%

Replicate 3

37.17

38.24

15.00

97.21

Y

Replicate 1

54.83

53.23

29.99

103.01

Y

Replicate 2

51.64

53.23

29.99

97.01

Y

120%

Replicate 3

51.88

53.23

29.99

97.45

Y

Acceptance Criteria: All individual recovery results should be within 90 % to 110 %.

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