90 / 670
5841 v2
Page 4 of 9
AsureQuality Laboratory Services
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.
Bio-02 (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE