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Method Validation Report
Version
1
Page
16 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 18B: Ruggedness of Stage 3 Growing up milk formula powder
Concentration (mcg/100g)
Pyridoxine Pyridoxal Pyridoxamine
Vit B6 (as
Pyridoxine)
Biotin
Day 1
1094.41
107.34
13.39
1216.51
14.11
Day 2
1193.98
113.60
13.89
1322.93
13.70
Day 3
1122.37
111.53
13.25
1248.58
14.73
Day 4
1148.26
111.87
13.97
1275.53
13.26
Day 5
1083.26
110.59
13.38
1208.65
14.90
Day 6
1103.16
111.61
13.92
1230.12
14.33
Mean
1124.24
111.09
13.63
1250.39
14.17
% RSD
3.66
1.87
2.39
3.43
4.38
Acetance
Criteria
≤5%
≤5%
≤5%
≤5%
≤5%
Accetable
(Y/N)
Y
Y
Y
Y
Y
Remark: Vitamin B6 (as Pyridoxine) is sum of Pyridoxine, Pyridoxal and Pyridoxamine.
All data have been mass corrected and expressed as Pyridoxine.
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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