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5841 v2

Page 3 of 9

AsureQuality Laboratory Services

TABLE OF CONTENTS

Section

Description

Page

1

Introduction

4

2

References

4

3

Scope

4

4

Validation Samples

5

5

Single Laboratory Validation

6

5.1

Methodology

6

5.2

Specificity / Blanks

6

5.3

Identification of biotin

6

5.4

Linearity and range

6

5.5

Accuracy / Recovery

6

5.6

Precision (Repeatability)

7

6

Summary and conclusion

8

Note only include the relevant topics from the table in the report.

Other pages attached:

Yes

No

Appendix 1: Proposed Method

Appendix 2: Reagent Blank

Appendix 3: Placebo

Appendix 4: Linearity and Slope

Appendix 5: Typical Standard Chromatogram

Appendix 6: Typical Sample Chromatogram

Bio-02 (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE