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Method Validation Report
Version
1
Page
17 of 49
Document Title
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
Table 19A: Ruggedness of Stage 1 Infant formula powder (milk-based)
Concentration (mcg/100g)
Thiamine
HCl
Riboflavin
Nicotinic
acid
Nicotinamide
Niacin
Pantothenic
acid
Day 1
587.04
1113.19
169.91
5661.20
5831.11
3889.35
Day 2
587.45
1147.83
175.15
5818.24
5993.4
3851.99
Day 3
559.80
1099.31
168.74
5720.66
5889.4
3740.91
Day 4
610.35
1105.86
170.49
5807.32
5977.81
3911.16
Day 5
605.80
1233.69
174.57
5910.39
6084.96
4308.14
Day 6
561.91
1080.08
179.12
6035.30
6214.42
3926.01
Mean
585.39
1129.99
173.00
5825.52
5998.52
3937.93
% RSD
3.63
4.91
2.29
2.30
2.29
4.90
Acetance
Criteria
5%
5%
5%
5%
5%
5%
Accetable
(Y/N)
Y
Y
Y
Y
Y
Y
Remark: Niacin is sum of Nicotinic acid and Nicotinamide, and reported as Niacin.
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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