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Method Validation Report
Version
1
Page
8 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 10: Instrument Precision of Nicotinamide, Pantothenic acid and Pyridoxine
Nicotinamide
Pantothenic acid
Pyridoxine
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
0.2706
0.5861
1.5690
0.1829
1.0950
3.3660
0.1472
0.8821
2.6880
Replicate 2
0.2686
0.6026
1.5670
0.1911
1.1220
3.3540
0.1493
0.8900
2.6170
Replicate 3
0.2631
0.6001
1.5380
0.1889
1.1150
3.2970
0.1445
0.8750
2.6720
Replicate 4
0.2690
0.5964
1.5610
0.1830
1.0810
3.2430
0.1477
0.8843
2.6720
Replicate 5
0.2716
0.6018
1.5720
0.1879
1.0870
3.2720
0.1476
0.8913
2.6860
Replicate 6
0.2631
0.5938
1.5570
0.1826
1.0990
3.2300
0.1433
0.8957
2.6460
Mean
0.2677
0.5968
1.5607
0.1861
1.0998
3.2937
0.1466
0.8864
2.6635
Std. Dev.
0.0037
0.0062
0.0124
0.0037
0.0159
0.0565
0.0022
0.0074
0.0273
% RSD
1.38
1.04
0.79
1.98
1.45
1.72
1.53
0.84
1.02
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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