AOAC SPIFAN Review Team Meeting Book-July 22, 2015
BVIT-01 (SLV) FOR ERP/WORKING GROUP USE ONLY DO NOT DISTRIBUTE
Method Validation Report
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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
Document Title
Standard 6 Standard 7 Standard 8 Standard 9 Standard 10 Y-Intercept Correlation Coefficient Acceptance Criteria Standard 1 Standard 2 Standard 3 Standard 4 Standard 5 Standard 6 Standard 7 Standard 8 Standard 9 Standard 10 Y-Intercept Correlation Coefficient Acceptance Criteria Slope Slope
694.13 832.95 971.78 1110.61 1249.43
1.8180 2.2040 2.5800 2.8160 3.3060 0.00263 0.00339
1.8140 2.1680 2.6430 2.9530 3.3050 0.00264 0.0013
1.8100 2.1550 2.6310 2.8770 3.3090 0.00263 0.00479
(weighting: 1/x)
0.99978
0.99981
0.99977
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)
17.41 34.82 69.65
0.1422 0.2890 0.5709 0.8593 1.1150 1.4320 1.7500 2.0880 2.3220 2.6410 0.00847 -0.02032
0.1422 0.2943 0.5541 0.8508 1.1270 1.4380 1.6940 1.9920 2.2620 2.5390 0.00812 0.00262
0.1411 0.2823 0.5564 0.8433 1.1070 1.4100 1.6930 1.9530 2.2460 2.5080 0.00803 0.00119
104.47
139.3
174.12 208.95 243.77
278.6
313.42
(weighting: 1/x)
0.99962
0.99992
0.99997
Correlation Coeffic ient (r) ≥ 0.995
Acceptable Y/N
Y
Y
Y
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