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Method Validation Report

Version

1

Page

1 of 49

Document Title

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

I. BACKGROUND

Method 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.

II. TEST SAMPLES:

No.

Matrix/Test Sample

1

Reference Material SRM 1849a Infant formula

2

Stage 3 Growing up milk formula powder

3

Stage 1 Infant formula powder(milk-based)

4

Partially hydrolyzed protein infant formula powder

III. VALIDATION DATA:

1. Linearity

Table 1: Linearity of Thiamine HCl

Cncentration

Area

Response 1

Area

Response 2

Area

Response 3

(ng/ml)

Standard 1

16.3

0.1819

0.1845

0.1844

Standard 2

32.6

0.3343

0.3334

0.3325

Standard 3

65.2

0.6785

0.6860

0.6762

Standard 4

97.81

1.0010

1.0080

1.0170

Standard 5

130.41

1.3670

1.3580

1.3650

Standard 6

163.01

1.6950

1.6890

1.6880

Standard 7

195.61

2.0360

2.0610

2.0250

Standard 8

228.21

2.4280

2.4170

2.3980

Standard 9

260.82

2.7740

2.7830

2.7530

Standard 10

293.42

3.1000

3.0850

3.1010

Slope

(weighting: 1/x)

0.01049

0.0105

0.01045

Y-Intercept

0.0027

0.00331

0.00401

Correlation

Coefficient

0.99983

0.99984

0.99987

Acceptance

Criteria

Correlation Coefficient (r) ≥ 0.995

Acceptable Y/N

Y

Y

Y

BVIT-01 (SLV)

FOR ERP/WORKING GROUP USE ONLY

DO NOT DISTRIBUTE

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