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 19B: Ruggedness of Stage 1 Infant formula powder (milk-based)

Concentration (mcg/100g)

Vit B6 (as Pyridoxine)

Pyridoxine

Pyridoxal

Pyridoxamine

Biotin 21.97

Day 1 Day 2

322.93

47.22

20.52

391.36

325.07

45.82

21.63

393.19

23.02

Day 3

315.45

43.30

22.20

381.60

21.86

Day 4

296.81

43.50

20.44

361.39

23.24

Day 5 Day 6 Mean

326.50 321.64 318.06

44.13 42.89 44.48

22.56 22.01 21.56

393.85 387.18 384.76

22.96 23.16 22.70

% RSD

3.49

3.81

4.12

3.20

2.71

Acetance Criteria Accetable (Y/N)

 5%

 5%

 5%

 5%

 5%

Y Y Remark: Vitamin B6 (as Pyridoxine) is sum of Pyridoxine, Pyridoxal and Pyridoxamine. All data have been mass corrected and expressed as Pyridoxine. Y Y Y

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