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

Table 8: Linearity of Pyridoxamine Concentration

Area Response 1

Area Response 2

Area Response 3

(ng/ml)

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 Standard 1 Standard 2 Standard 3 Standard 4 Standard 5 Standard 6 Standard 7 Standard 8 Standard 9 Standard 10 Slope

0.7

0.1111 0.2231 0.4255 0.6261 0.9056 1.1190 1.3070 1.5710 1.7530 1.9900 0.1578 0.0063

0.1088 0.2162 0.4233 0.6297 0.8677 1.0830 1.2920 1.5480 1.7350 1.9830 0.15515 0.00382

0.1110 0.2148 0.4334 0.6347 0.8746 1.1140 1.2870 1.4990 1.7360 1.9890 0.1547

1.41 2.81 4.22 5.62 7.03 8.44 9.84

11.25 12.65

(weighting: 1/x)

-0.000301

0.99955

0.99982

0.99978

Correlation Coefficient (r) ≥ 0.995

Acceptable Y/N

Y

Y

Y

Table 8: Linearity of Biotin Concentration

Area Response 1

Area Response 2

Area Response 3

(ng/ml)

0.71 1.41 2.83 4.24 5.66 7.07 8.49

0.0544 0.1075 0.2183 0.3064 0.4148 0.5337 0.6006 0.7429 0.8040 0.9213

0.0543 0.1103 0.2145 0.3167 0.4276 0.5297 0.6337 0.7173 0.8040 0.9226

0.0536 0.1095 0.2235 0.3316 0.4268 0.5231 0.6157 0.7443 0.8374 0.9188

9.9

11.32 12.73

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