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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