AOAC SPIFAN Review Team Meeting Book-July 22, 2015

BVIT-01 (SLV) FOR ERP/WORKING GROUP USE ONLY DO NOT DISTRIBUTE

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 48: Accuracy of Biotin in Partially hydrolyzed protein infant formula powder

Biotin (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 21.94

Mean

Replicate 2 22.72

22.51

0%

Replicate 3 22.86

Replicate 1

35.87

33.82

11.32

106.07

Y

Replicate 2

35.07

33.82

11.32

103.69

Y

50%

Replicate 3

35.78

33.82

11.32

105.79

Y

Replicate 1

47.37

45.14

22.63

104.96

Y

Replicate 2

46.98

45.14

22.63

104.08

Y

100%

Replicate 3

47.43

45.14

22.63

105.08

Y

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

IV. CONCLUSION

The results documented in this report confirmed that the acceptance criteria outlined in SMPR were met.

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