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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

Y-Intercept Correlation Coefficient Acceptance Criteria

0.07455

0.06582

0.07738

0.99853

0.99872

0.9994

Correlation Coefficient (r) ≥ 0.995

Acceptable Y/N

Y

Y

Y

Table 4: Linearity of Nicotinamide Run 1-3 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 Y-Intercept Correlation Coefficient Acceptance Criteria Slope

279.91 559.82 839.72 1119.63 1399.54 1679.45 1959.35 2239.26 2519.17

0.3722 0.6992 1.0090 1.3370 1.5960 1.9120 2.1700 2.4390 2.6420 0.00105 0.10056

0.3712 0.6917

0.3749 0.7025 0.9838

0.991 1.317 1.633 1.857 2.178 2.393 2.715

1.296 1.577

1.86

2.115

2.41

2.654

(weighting: 1/x)

0.00106 0.09266

0.00104 0.10409

0.99879

0.99919

0.99947

Correlation Coefficient (r) ≥ 0.995

Acceptable Y/N

Y

Y

Y

Table 5: Linearity of Pantothenic acid Concentration Area Response 1

Area Response 2

Area Response 3

(ng/ml)

Standard 1 Standard 2 Standard 3 Standard 4 Standard 5

69.41

0.1864 0.3718 0.7323 1.0950 1.4720

0.1878 0.3709 0.7339 1.0870 1.4550

0.1848 0.3738 0.7374 1.1110 1.4540

138.83 277.65 416.48

555.3

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