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Method Validation Report
Version
1
Page
13 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
6. Quantitation Limit
Analyze 6 replicates of the lowest standard concentration. Calculated RSD should be
<5% for each analyte.
Table 15: Quantitation Limit of Thiamine HCl, Riboflavin, Nicotinic acid, Nicotinamide and
Pantothenic acid
Area Ratio
Lowest Standard
Thiamine HCl Riboflavin
Nicotinic
acid
Nicotinamide
Pantothenic
acid
Replicate 1
0.18600
0.12820
0.22460
0.27060
0.18690
Replicate 2
0.18430
0.12310
0.22270
0.26860
0.18250
Replicate 3
0.18250
0.12540
0.22400
0.26310
0.18200
Replicate 4
0.18250
0.12430
0.22360
0.26900
0.18650
Replicate 5
0.18250
0.12370
0.21410
0.27160
0.18550
Replicate 6
0.18140
0.12700
0.21660
0.26310
0.18360
Mean
0.18320
0.12528
0.22093
0.26767
0.18450
Std. Dev.
0.00166
0.00199
0.00444
0.00370
0.00209
% RSD
0.91
1.58
2.01
1.38
1.13
Acceptance
Criteria
RSD ≤ 5%
RSD ≤
5%
RSD ≤ 5%
RSD ≤ 5%
RSD ≤ 5%
%RSD
Acceptable
(Y/N)
Y
Y
Y
Y
Y
Quantitation
Limit
(mcg/100g)
26.08
31.35
13.03
441.93
111.06
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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