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AOAC First Action Method 2016.02 (Biotin) MLT Report

Page 2 of 16

TABLE OF CONTENTS

Section

Description

Page

1

Introduction

3

1.1

Study Title

3

1.2

Study Objective

3

1.3

Study Director

3

1.4

Study Monitor

3

1.5

Abbreviations

3

2

The MLT Overview

3

2.1

Method set up and qualification of participants

3

2.2

Multi laboratory testing by qualified participants

4

2.3

Statistical evaluation

4

3

Materials and Methods

4

3.1

AOAC SPIFAN Matrices

4

3.2

Collaborating laboratories

5

3.3

Analytical method

5

4

Results and Discussion

10

4.1

The overview

10

4.2

Linearity and Range

11

4.3

MLT Results and Statistical Evaluation

11

4.4

Relative Standard Deviation of Repeatability (RSDr)

11

4.5

Relative Standard Deviation of Reproducibility (RSDR)

12

4.6

Horwitz Ratio (HorRat)

12

4.7

Accuracy (NIST SRM 1849a)

12

4.8

Selectivity (Comparison with LCMS/MS

12

5

Summary and Conclusion

15

6

Recommendations

15

7

Notes from the Study Director

15

8

References

16

9

Acknowledgements

16

Tables / Figures

Title

Page

Table 1

AOAC SPIFAN Matrices

4

Table 2

MLT Participants

5

Table 3

HPLC Gradient Program

8

Table 4

Retention times and correlation coefficients

11

Table 5

Biotin (µg/100g) Practice Samples

13

Table 6

Biotin (µg/100g) MLT samples (Day 1)

13

Table 7

Biotin (µg/100g) MLT samples (Day 2)

13

Table 8

Statistical evaluation biotin results

14

Table 9

Comparison with LCMS/MS technique

14

Table 10

Comparison of method performance

15

Figure 1

Calibration standard

9

Figure 2

MLT Sample 8B (00859RF00 / PZGP859)

10

2016.02 (FEBRUARY 2017) BIO-02 MLT REPORT

FOR ERP USE ONLY

DO NOT DISTRIBUTE