39 / 129
Method Validation Report
Version
1
Page
3 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
Y-Intercept
0.07455
0.06582
0.07738
Correlation
Coefficient
0.99853
0.99872
0.9994
Acceptance
Criteria
Correlation Coefficient (r) ≥ 0.995
Acceptable Y/N
Y
Y
Y
Table 4: Linearity of Nicotinamide Run 1-3
Concentration
Area
Response 1
Area
Response 2
Area
Response 3
(ng/ml)
Standard 1
279.91
0.3722
0.3712
0.3749
Standard 2
559.82
0.6992
0.6917
0.7025
Standard 3
839.72
1.0090
0.991
0.9838
Standard 4
1119.63
1.3370
1.317
1.296
Standard 5
1399.54
1.5960
1.633
1.577
Standard 6
1679.45
1.9120
1.857
1.86
Standard 7
1959.35
2.1700
2.178
2.115
Standard 8
2239.26
2.4390
2.393
2.41
Standard 9
2519.17
2.6420
2.715
2.654
Slope
(weighting: 1/x)
0.00105
0.00106
0.00104
Y-Intercept
0.10056
0.09266
0.10409
Correlation
Coefficient
0.99879
0.99919
0.99947
Acceptance
Criteria
Correlation Coefficient (r) ≥ 0.995
Acceptable Y/N
Y
Y
Y
Table 5: Linearity of Pantothenic acid
Concentration
Area
Response 1
Area
Response 2
Area
Response 3
(ng/ml)
Standard 1
69.41
0.1864
0.1878
0.1848
Standard 2
138.83
0.3718
0.3709
0.3738
Standard 3
277.65
0.7323
0.7339
0.7374
Standard 4
416.48
1.0950
1.0870
1.1110
Standard 5
555.3
1.4720
1.4550
1.4540
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
Page 16