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

Concentration (mcg/100g)

Thiamine HCl

Riboflavin Nicotinic acid

Pantothenic acid

Nicotinamide

Niacin

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Mean

587.04 587.45 559.80 610.35 605.80 561.91 585.39

1113.19 1147.83 1099.31 1105.86 1233.69 1080.08 1129.99

169.91 175.15 168.74 170.49 174.57 179.12 173.00

5661.20 5818.24 5720.66 5807.32 5910.39 6035.30 5825.52

5831.11 5993.4 5889.4 5977.81 6084.96 6214.42 5998.52

3889.35 3851.99 3740.91 3911.16 4308.14 3926.01 3937.93

% RSD

3.63

4.91

2.29

2.30

2.29

4.90

Acetance Criteria Accetable (Y/N)

 5%

 5%

 5%

 5%

 5%

 5%

Y Y Remark: Niacin is sum of Nicotinic acid and Nicotinamide, and reported as Niacin. Y Y Y Y

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