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

Yes. System suitability is presented. Method uncertainty is well defined and calculated, with the reported extended uncertainty at 18.9%. The results from the Method LAC-001 were compared with an alternative method. The reviewer assumes that the identical sample extraction procedure was adopted, and the sample extracts were analyzed by a LC-MS/MS method.

Yes. Addressed in the previous Question 2.

Although some of the sentences could be written better (or English translation needs to be more specific), the report is well written.

Pros: This method seems to be capable of delineating almost all the potential interferants listed in SMPR.

Cons: Only drawback of this rather a laborious method is that there will not be many labs capable of running IC methods routinely, esp. in the developing countries.

7. Any general comments about the method?

N/A

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.

The reviewer strongly recommends this method be adopted as a First Action, based upon the rationale that this method demonstrated its superior (?) sensitivity of lactose in free- or low-lactose milk products and the selectivity (against potential interferants).