AOAC SPIFAN Review Team Meeting Book-July 22, 2015

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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 11: Instrument Precision of Pyridoxal, Pyridoxamine and Biotin Pyridoxal Pyridoxamine

Biotin

Area Ratio

Area Ratio

Area Ratio

Lowest Standard

Middle Standard

Highest Standard

Lowest Standard

Middle Standard

Highest Standard

Lowest Standard

Middle Standard

Highest Standard

Replicate 1

0.0312

0.3016

5.2980

0.1121

0.6782

2.0540

0.0562

0.3204

0.9182

Replicate 2

0.0318

0.2938

5.3870

0.1114

0.6653

2.0840

0.0537

0.3176

0.9130

Replicate 3

0.0293

0.2958

5.3060

0.1133

0.6683

2.0950

0.0531

0.3131

0.9165

Replicate 4

0.0311

0.3023

5.5420

0.1140

0.6751

2.0640

0.0560

0.3174

0.8979

Replicate 5

0.0322

0.3046

5.3960

0.1110

0.7008

2.0380

0.0547

0.3122

0.8930

Replicate 6

0.0320

0.2926

5.5650

0.1099

0.6847

1.9180

0.0530

0.3112

0.9014

Mean

0.0313 0.0011

0.2985 0.0050

5.4157 0.1143

0.1120 0.0015

0.6787 0.0128

2.0422 0.0642

0.0544 0.0014

0.3153 0.0037

0.9067 0.0106

Std. Dev.

% RSD

3.36

1.68

2.11

1.35

1.89

3.14

2.61

1.16

1.17

Acceptance Criteria %RSD Acceptable (Y/N)

RSD ≤ 5%

RSD ≤ 3%

RSD ≤ 3%

RSD ≤ 5%

RSD ≤ 3%

RSD ≤ 3%

RSD ≤ 5%

RSD ≤ 3%

RSD ≤ 3%

Y

Y

Y

Y

Y

Y

Y

Y

Y

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