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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 33: Accuracy of Nicotinic acid in Stage 1 Infant formula powder(milk-based)

Nicotinic acid (mcg/100g)

Un- spiked Result

Resulting Spiked Conc

Spiked Result

% Recovery

Over Spike

Acceptable

Theoretical Spiked Conc (C)

Replicates

(A)

(B)

(A+C)

B/(A+C)

Y/N

Replicate 1 177.44

Mean

Replicate 2 180.53

181.32

0%

Replicate 3 186.01

Replicate 1

253.73

268.18

86.85

94.61

Y

Replicate 2

262.33

268.18

86.85

97.82

Y

50%

Replicate 3

253.38

268.18

86.85

94.48

Y

Replicate 1

334.41

355.03

173.71

94.19

Y

100%

Replicate 2

346.20

355.03

173.71

97.51

Y

Replicate 3

338.53

355.03

173.71

95.35

Y

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

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