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Method Validation Report
Version
1
Page
4 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
Standard 6
694.13
1.8180
1.8140
1.8100
Standard 7
832.95
2.2040
2.1680
2.1550
Standard 8
971.78
2.5800
2.6430
2.6310
Standard 9
1110.61
2.8160
2.9530
2.8770
Standard 10
1249.43
3.3060
3.3050
3.3090
Slope
(weighting: 1/x)
0.00263
0.00264
0.00263
Y-Intercept
0.00339
0.0013
0.00479
Correlation
Coefficient
0.99978
0.99981
0.99977
Acceptance
Criteria
Corre
lation Coefficient (r) ≥ 0.995
Acceptable Y/N
Y
Y
Y
Table 6: Linearity of Pyridoxine
Concentration
Area
Response 1
Area
Response 2
Area
Response 3
(ng/ml)
Standard 1
17.41
0.1422
0.1422
0.1411
Standard 2
34.82
0.2890
0.2943
0.2823
Standard 3
69.65
0.5709
0.5541
0.5564
Standard 4
104.47
0.8593
0.8508
0.8433
Standard 5
139.3
1.1150
1.1270
1.1070
Standard 6
174.12
1.4320
1.4380
1.4100
Standard 7
208.95
1.7500
1.6940
1.6930
Standard 8
243.77
2.0880
1.9920
1.9530
Standard 9
278.6
2.3220
2.2620
2.2460
Standard 10
313.42
2.6410
2.5390
2.5080
Slope
(weighting: 1/x)
0.00847
0.00812
0.00803
Y-Intercept
-0.02032
0.00262
0.00119
Correlation
Coefficient
0.99962
0.99992
0.99997
Acceptance
Criteria
Correlation Coeffic
ient (r) ≥ 0.995
Acceptable Y/N
Y
Y
Y
BVIT-01 (SLV)
FOR ERP/WORKING GROUP USE ONLY
DO NOT DISTRIBUTE
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