AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

Summary comparison of 2011.18 (Abbott) & 2012.12 (Covance) • Both methods provide essentially equivalent i) sample preparation for free inositol determination, and ii) similar analytical HPIE-PAD procedures. 2011.18: 2 extns/analyses to aggregate total [free + PI-derived] inositol. 2012.12: 1 extn/analysis for total [free + PI-derived + IP-derived] inositol.

2011.18 incorporates column-switching • 2012.12 does not utilize column-switching.

2011.18 comply with the specific SMPR statement, but requires 2 assays. • 2012.12 does not meet SMPR requirement by including IPs and phytate in a total inositol measurement .

Method Repeal?

1 st Action 2012.12 is in use by several labs, possibly due to operational simplicity (single assay for either free or total inositol, and no column switching) . Summary statement : although both yield similar results when applied to the analysis of free myo -inositol, there are differences when applied to bound analyte due to differences in sample preparation: AOAC 2012.12 adopts an exhaustive acid hydrolysis to recover total myo -inositol prior to end-point analysis AOAC 2011.18 aggregates free and phosphatidyl-bound myo -inositol, which are estimated in two separate determinations. 2011.18: 1 st Action, MLT and Final Action 2012.12: 1 st Action only for non-soy formulas, SLV only performed on one milk and one soy matrix, MLT not performed (Question: could users QC data be collated to support ERP/OMB Final Action approval?) In the absence of a regulatory analyte definition, can measure either i) free myo -inositol only, or ii) total myo -inositol, either of which can currently satisfy Codex requirements.

The Co-Chairs are in agreement and do not recommend repeal of 2012.12