Review Team (February 2016)

Bio-02 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

1. INTRODUCTION

Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) is an activity mooted by AOAC International and funded by the Infant Nutritional Council of America (INCA). SPIFAN has been founded to develop global standards (dispute resolution methods) for significant nutrients in infant formula and adult nutritionals. AOAC SPIFAN activity launched biotin in August 2013. An AOAC Expert Review Panels will approve one method for Biotin analysis that has undergone single laboratory validation (SLV) as First Action Official Method. The approved method will eventually undergo multi-laboratory testing (MLT) in support of achieving Final Action Official Method status. AsureQuality Auckland Laboratory has initiated a method to facilitate a specific, precise, accurate and robust procedure for the analysis of biotin from Infant Formula and Adult / Pediatric Nutritional Formulas. The method also has an assured limit of quantification of 0.1μg/100g (1ppb) based on a simple mathematical relationship between lowest standard and dilution. The method involves immunoaffinity column (R-Biopharm Rhone, EASI- EXTRACT biotin column or equivalent) clean-up and extraction followed by liquid chromatography with UV detection. The purpose of this report is to document a single laboratory validation performed as per the AOAC SLV guidelines using SPIFAN matrices. The overall method performance is evaluated using SLV data and is compared to biotin SMPR 2014.005, March 18 2014. 2. REFERENCES 1. AOAC SMPR 2014.005; Final; March 18, 2014: Standard Method Performance Requirements for Biotin in Infant and Adult/Paediatric Nutritional Formula. 2. AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Single Laboratory Validation; September 2011. 3. EASI-EXTRACT® Biotin; Immunoaffinity columns for use in conjunction with HPLC or LC-MS/MS, R-Biopharm Rhone Ltd. 3. SCOPE This validation has been designed to demonstrate the performance of the biotin method by AsureQuality / R-Biopharm Rhone Ltd (Bio-02) and to prove the suitability of the method as a SPIFAN Global standard for infant formula and adult / paediatric nutritional formula as per AOAC SMPR 2014.005, March 18 2014. Specially selected SPIFAN SLV kit materials (matrices) supplied to the laboratory by AOAC International were used for the validation.

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