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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 29: Accuracy of Pyridoxamine in Stage 3 Growing up milk formula powder

Pyridoxamine (mcg/100g)

Un- spiked Result

Resulting Spiked Conc

Over Spike

Spiked Result

% Recovery

Replicates

Acceptable

Theoretical Spiked Conc (C)

(A)

(B)

(A+C)

B/(A+C)

Y/N

Replicate 1 14.70

Mean

Replicate 2 13.07

14.01

0%

Replicate 3 14.26

Replicate 1

20.04

21.51

7.50

93.19

Y

50%

Replicate 2

20.98

21.51

7.50

97.57

Y

Replicate 3 Replicate 1 Replicate 2

20.96 28.57 28.62

21.51 29.00 29.00

7.50

97.45 98.51 98.67

Y Y Y

15.00 15.00

100%

Replicate 3

28.05

29.00

15.00

96.72

Y

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

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