Low Lactose ERP - Review Book

IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 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?

No

No SST are mentioned. It could be good to add a check standard or a check sample.

No SST are mentioned.

The method is clear and well written. The voltage of the MS-capillary must be in KILO-volt?

Easy to perform. Very good resolution of lactose from other possible present sugars in the sample.

MS detectors are not present in all labs. Very expensive internal standards (labelled sugars) for routine analysis.

7. Any general comments about the method?

Good but expensive method. More data is needed.

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.

I do not recommend moving forward the method currently. I consider is a good method, but more data is needed.