AOAC SPIFAN Nutrients ERP Reviewer Forms (December 7, 2022)

FOR EXPERT REVIEW PANEL USE ONLY NOT FOR DISTRIBUTION

1. Is the Validation Study Report in a format acceptable to AOAC? No 2. Is the method described in sufficient detail so that it is relatively easy to understand, including equations and procedures for calculation of results (are all terms explained)? No 3. Are the figures and tables sufficiently explanatory without the need to refer to the text? Yes 4. Are all the figures and tables pertinent? Yes 5. Could some be omitted and covered by a simple statement? No 6. Are the references complete and correctly annotated? Yes 7. Does the method contain adequate safety precaution reference and/or statements? No Recommendation: I do not recommend this method for first action status as it does not cover the SMPR LOQs for 3 of the 7 HMOs and it does not meet RSD r for all 7 HMOs at the bottom of the validated range (2.5 mg/100g). Additionally, the method ruggedness is unclear as very few matrices have been evaluated. I have additional concerns about the apparent 21% disconnect observed in QC E2 for LNnT. Lastly, it does not appear that one of the reagents used is commercially available which would severely limit the ability of the method to be generally adopted.

3