AOAC OMA# 2011.06 Final Action Review-OMB

2011.06 (September 2017)-Fol-22 MLT Report

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Summary: A multi-laboratory collaborative study of the AOAC First Action Method 2011.06 (FOL- 22), Analysis of Total Folates in Infant Formula and Adult Nutritionals by Trienzyme Extraction and UPLC-MS/MS Quantitation was undertaken. The study consisted of analyses of blind duplicates of 11 infant formula and adult nutritional products including one reference material NIST SRM 1869a. The analyses of the samples was performed by 11 different laboratories from 6 countries. Precision as repeatability ranged from 3.5-6.6%, RSD r and reproducibility values ranged from 9.0 to 15.7% RSD R . For all SPIFAN samples analyzed in the MLT study were within the limits set in the Folate SMPR (AOAC 2011.006). Acceptable reproducibility was also demonstrated with better than expected HorRat R values for the method ranging from 0.61-1.06 (expected range 0.5-2.0). On the basis of the results of this multi-laboratory collaborative study, it is recommended that the AOAC First Action Method 2011.06 (Folate-22) be endorsed as a Final Action method for the determination of Total Folates in Infant Formula and Adult Nutritionals, Trienzyme Extraction and UPLC-MS/MS Quantitation. 1. INTRODUCTION

1.1 Study Title:

Analysis of Total Folates in Infant Formula and Adult Nutritionals by Trienzyme Extraction and UPLC-MS/MS Quantitation, AOAC First Action 2011.06 (Folate-22): Multi-Laboratory Study

1.2 Objective:

The objective of the study was to validate the current method (AOAC First Action 2011.06 (FOlate-22)) by determining its precision figures (repeatability and reproducibility) through a multi-laboratory testing (MLT). This is mandatory to finalize the work in progress and go forward to obtain Final Action status. 1.3 Study Director : Sneh D. Bhandari, Ph.D. , Merieux NutriSciences, Crete, IL 60417, USA Sneh.bhandari@mxns.com 1.4 Associate Study Director: John Szpylka, Ph.D. Merieux NutriSciences, Crete, IL 60417, USA john.szpylka@mxns.com

1.5 Author of the MLT Report: Sneh D. Bhandari, Ph.D. R&D Director

Collaborative Study Report: Method AOAC 2011.06 (Folate by LC-MS/MS) 3