AOAC SPIFAN ERP Report (August 5, 2021)

AOAC SPIFAN Expert Review Panel Report August 5, 2021 Version 1

Method Title

Reviewer(s)

Vote

Method

Comments

(HMO-01) - Method for the Determination of 2’- Fucosyllactose, 6’-Sialyllactose, and 3’-Sialyllactose by High Performance Anion Exchange Chromatography, with Pulsed Amperometric Detection

HMO

See recommendations:

Sean Austin Brendon Gill

Motion: To recommend method as First Action

Brendon Gill moved *No second

HMO-01 RECOMMENDATIONS FROM ERP: 1. Blank matrix 2. Larger chromatogram 3. Guidance on how cross impurities in combined standards are accounted for 4. Clarification of calibration standard calculation; how are the impurities other than moisture accounted for? Motion: Sean Austin/Brendon Gill Abstain: Abbott Nutrition

Recommendation from HMO-01 Reviewers:

 Based on the data presented I am confident this method is likely fit for purpose; however, I think the reporting needs to be improved so the design of the validation experiments is more clearly reported, and the method could be easier to follow.  I would like to see spike/recovery data at concentrations inside the SMPR to assess if the recovery is still within the requirements at lower spike levels for the following matrices: - o SPIFAN III adult powder (sucrose, 2’-FL) o Soy-based IF powder (sucrose)  I would like to see some calibration plots and plots of residuals  I would like to see LoQs confirmed by low spikes in blank matrices  I would like to see if the authors have checked that 3’SL and 6’SL are well separated from their N-glycolylneuraminyllactose counterparts.  No matrices containing probiotics have been included. So, we can either limit the scope to exclude those or give the authors time to test such matrices.

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