OMB Meeting Book_9-11-14

Vitamin A & E MLT Protocol For ERP Use Only DO NOT DISTRIBUTE

Introduction

Thank you for accepting the invitation to participate in the AOAC collaborative study for the validation of the method for the determination of i13-Cis and all-trans Vitamin A Palmitate (retinyl palmitate), Vitamin A Acetate (retinyl acetate), and Total Vitamin E (α-Tocopherol and DL-α-Tocopherol Acetate) in Infant Formula and Adult Nutritionals by Normal Phase HPLC. It is important to remember that this is a test of the methodology involved and not a test of the individual laboratories or their personnel. In this regard, it is very important to follow these directions and the enclosed method exactly. If for any reason you are not able to complete the study, please contact the Study Director as soon as possible.

Overview

Your participation in this study will consist of three parts.

a) The first will be instrument setup, check procedure and preparation of reagents and calibration standards. Before running any samples run the System Suitability checks as outlined in the method to ensure that the system is working as specified. The results of the System Suitability checks must be included in the results sent to the study director. b) The second phase will be the analysis of practice samples. For laboratories that are unfamiliar with the method, practice samples such as reference materials will be analysed in order to become familiar with the complete analysis procedure. This will ensure that instrumentation is working properly and reagents/solutions/calibration standards are all prepared correctly in advance of conducting the actual study. These results will be submitted to the study director for approval prior to commencing the MLT. Results within a range of expected levels will indicated that the laboratory has the capability to run the analysis successfully. c) The third phase will consist of the analysis of the actual test materials following the go ahead from the study director. After the determinations are complete, the results will be returned to the Study Director for review. The results from all collaborators will be compiled by the Study Director and sent to the AOAC Statistician for detailed analysis. Upon approval by the statistician, the study report will be written and submitted to the AOAC Methods Committee for review and approval as an Official First Action AOAC Method, and subsequent publication in the Journal of AOAC INTERNATIONAL.

A more detailed description of the work required in the form of a flow diagram is presented in Figure 1.

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