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Method Validation Report
Version
1
Page
9 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 11: Instrument Precision of Pyridoxal, Pyridoxamine and Biotin
Pyridoxal
Pyridoxamine
Biotin
Area Ratio
Area Ratio
Area Ratio
Lowest
Standard
Middle
Standard
Highest
Standard
Lowest
Standard
Middle
Standard
Highest
Standard
Lowest
Standard
Middle
Standard
Highest
Standard
Replicate 1
0.0312
0.3016
5.2980
0.1121
0.6782
2.0540
0.0562
0.3204
0.9182
Replicate 2
0.0318
0.2938
5.3870
0.1114
0.6653
2.0840
0.0537
0.3176
0.9130
Replicate 3
0.0293
0.2958
5.3060
0.1133
0.6683
2.0950
0.0531
0.3131
0.9165
Replicate 4
0.0311
0.3023
5.5420
0.1140
0.6751
2.0640
0.0560
0.3174
0.8979
Replicate 5
0.0322
0.3046
5.3960
0.1110
0.7008
2.0380
0.0547
0.3122
0.8930
Replicate 6
0.0320
0.2926
5.5650
0.1099
0.6847
1.9180
0.0530
0.3112
0.9014
Mean
0.0313
0.2985
5.4157
0.1120
0.6787
2.0422
0.0544
0.3153
0.9067
Std. Dev.
0.0011
0.0050
0.1143
0.0015
0.0128
0.0642
0.0014
0.0037
0.0106
% RSD
3.36
1.68
2.11
1.35
1.89
3.14
2.61
1.16
1.17
Acceptance
Criteria
RSD ≤
5%
RSD ≤
3%
RSD ≤
3%
RSD ≤
5%
RSD ≤
3%
RSD ≤
3%
RSD ≤
5%
RSD ≤
3%
RSD ≤
3%
%RSD
Acceptable
(Y/N)
Y
Y
Y
Y
Y
Y
Y
Y
Y
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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