AOAC SPIFAN Review Team Meeting Book-July 22, 2015

BVIT-02 FOR ERP/WORKING GROUP USE ONLY DO NOT DISTRIBUTE

Simultaneous Determination of Total Vitamin B 6, B 2, B 3 in Infant Formula Products by LC-MS/MS Using Enzymatic Digestion and B 1

Document Summary

This is an AOAC method submission for the vitamin B group consisting of vitamins B 1 , B 2 , B 3 and B 6 . This is an Abbott method utilizing an enzymatic digestion and LC/MS analysis for the determination of the total content of all the vitamins of this group. This method submission will consist of three different sections. The first will contain precision data testing from the SPIFAN 1 sample kit which was generated in 2011. The second section will be the Abbott internal validation of this method for infant formula which was performed in 2009. The final section will be the test document itself. Each section will be described in greater detail below. SPIFAN Data summary (section 1): pg. 2 A full three day in duplicate precision analysis of the SPIFAN 1 sample kit is included in this section. The original scope of this method did not included vitamin B3, and is therefore not represented in this table. Just prior to this submission transitions for vitamin B 3 were added to the method, and some preliminary data were collected. The data includes the SRM 1849a and a few of the SPIFAN 2 matrices. That single day data for all five vitamins is also included in this section. Original Internal Validation (section 2): pg. 7 The original internal validation for this method was completed in early 2012 with the scope being only vitamins B 1 , B 2 , and B 6 . This section consists of the report for this validation. The report contains six days of precision data for the original SRM 1849, SRM 1846, and a milk based infant formula. Accuracy was assessed through two levels of spikes into an infant formula placebo. All of the phosphorylated vitamin forms were also spiked into the placebo formula, and SRM 1849.

Method document (section 3): pg. 18 This is the method document.

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