55 / 129
Method Validation Report
Version
1
Page
19 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
Concentration (mcg/100g)
Thiamine
HCl
Riboflavin Nicotinic
acid
Nicotinamide
Niacin
Pantothenic
acid
Day 1
620.71
1071.96
206.86
7513.77
7720.63
3445.36
Day 2
612.51
1003.50
200.64
6995.54
7196.17
3454.24
Day 3
605.50
1109.83
215.92
7344.98
7560.9
3448.02
Day 4
578.27
1031.76
224.52
7493.67
7718.19
3537.58
Day 5
602.73
1023.17
215.10
7490.49
7705.6
3750.07
Day 6
577.33
1016.23
226.18
7975.53
8201.71
3719.42
Mean
599.51
1042.74
214.87
7469.00
7683.87
3559.12
% RSD
2.99
3.86
4.60
4.23
4.21
3.95
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.
Table 20A: Ruggedness of
Partially hydrolyzed protein infant formula powder
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
Page 32