54 / 129
Method Validation Report
Version
1
Page
18 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 19B: Ruggedness of Stage 1 Infant formula powder (milk-based)
Concentration (mcg/100g)
Pyridoxine
Pyridoxal
Pyridoxamine
Vit B6 (as
Pyridoxine)
Biotin
Day 1
322.93
47.22
20.52
391.36
21.97
Day 2
325.07
45.82
21.63
393.19
23.02
Day 3
315.45
43.30
22.20
381.60
21.86
Day 4
296.81
43.50
20.44
361.39
23.24
Day 5
326.50
44.13
22.56
393.85
22.96
Day 6
321.64
42.89
22.01
387.18
23.16
Mean
318.06
44.48
21.56
384.76
22.70
% RSD
3.49
3.81
4.12
3.20
2.71
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
Page 31