Low Lactose ERP - Review Book

2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method?

yes

yes

In the 'Results and Discussion' section under 'calibration study', the following is stated in line 8: "constant concentrations of glucose and galactose (24 g each)". It is not clear what is meant by "24 g each". The authors need to give details on this (e.g which volume was used)

- fast - easy to use - no expensive laboratory instruments needed (> $ 50K) - readily implemented in factory labs - can be used by operators (no highly trained, expert chemical analysts needed)

6. Based on the supporting information, what are the cons/weaknesses of the method?

- limit of quantification is 8 mg/100 g and therefore not suited for measurement in infant formulas - applicability for dried dairy products is not shown

7. Any general comments about the method?

I am impressed by the large variety of natural matrices selected in this study and the good match of the LactoSense data for these matrices with HPAEC-PAD. This clearly shows the broad applicability of the LactoSense method for low- lactose matrices.

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

Yes, with a footnote that infant formulas and dried dairy products are not included in the LactoSense method