SPIFAN ERP Final Action Review (June 9, 2017)

AOAC First Action Method 2016.02 (Biotin) MLT Report

Page 3 of 16

1. INTRODUCTION

1.1. Study Title

Determination of biotin by liquid chromatography coupled with immunoaffinity column clean-up extraction,

AOAC International First Action Official Method 2016.02, Multi Laboratory Testing.

1.2. Study Objective

The objective of the MLT study is to establish the precision and accuracy of the method in various

laboratories to demonstrate the suitability of the method as an international reference method with

endorsement as AOAC Final Action, and possible adoption by ISO and Codex.

1.3. Study Director

Dr George Joseph PhD

Technical Manager - Chemistry

AsureQuality Limited

131 Boundary Road, Blockhouse Bay, Auckland 0600, New Zealand

PO Box 41, Shortland Street, Auckland 1140, New Zealand

Telephone: +64 9 6268237

Mobile: +64 21 364412

Email:

1.4. Study Monitor

The study is monitored by AOAC International (SPIFAN) Official Method Board or by its delegated

personnel.

1.5. Abbreviations

AOAC: Association of Official Analytical Chemists

SPIFAN: Stakeholder Panel on Infant Formula and Adult Nutritionals

ERP: Expert Review Panel

MLT: Multi Laboratory Testing

HPLC: High Performance Liquid Chromatography

UV: Ultraviolet

SMPR: Standard Method Performance Requirements

NIST SRM: National Institute of Standards and Technology, Standard Reference Material

2. THE MLT OVERVIEW

The study is divided in two parts: method set up and qualification of participants (Part 1) and multi

laboratory testing by the qualified participants (Part 2).

2.1. Method set up and qualification of participants

The participating laboratories were requested to analyse two practice samples in duplicate using the

method provided and report the results to the study director. It was communicated to the laboratories that

any deviation, such as necessity to substitute reagents, columns, apparatus or instruments, must be duly

recorded and reported. Electronic templates were provided to the participants for data reporting. Moreover

raw data was requested wherever necessary. After review, the study director identified the laboratories

which have the capability to run the analysis successfully. The study director also had discussion with those

laboratories produced unacceptable data to see any technical reasons which can be resolved within

reasonable time frame to include them in the second part of the study.

2016.02 (FEBRUARY 2017) BIO-02 MLT REPORT

FOR ERP USE ONLY

DO NOT DISTRIBUTE