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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 10: Instrument Precision of Nicotinamide, Pantothenic acid and Pyridoxine Nicotinamide Pantothenic acid

Pyridoxine 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

0.2706

0.5861

1.5690

0.1829

1.0950

3.3660

0.1472

0.8821

2.6880

Replicate 2

0.2686

0.6026

1.5670

0.1911

1.1220

3.3540

0.1493

0.8900

2.6170

Replicate 3

0.2631

0.6001

1.5380

0.1889

1.1150

3.2970

0.1445

0.8750

2.6720

Replicate 4

0.2690

0.5964

1.5610

0.1830

1.0810

3.2430

0.1477

0.8843

2.6720

Replicate 5

0.2716

0.6018

1.5720

0.1879

1.0870

3.2720

0.1476

0.8913

2.6860

Replicate 6

0.2631

0.5938

1.5570

0.1826

1.0990

3.2300

0.1433

0.8957

2.6460

Mean

0.2677 0.0037

0.5968 0.0062

1.5607 0.0124

0.1861 0.0037

1.0998 0.0159

3.2937 0.0565

0.1466 0.0022

0.8864 0.0074

2.6635 0.0273

Std. Dev.

% RSD

1.38

1.04

0.79

1.98

1.45

1.72

1.53

0.84

1.02

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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