AOAC SPDS Set 2 ERP

4. Is there information demonstrating that the method performs within the SMPR Method Performance Requirements table specifications for all analytes in the SMPR applicability statement? If no, please specify what is missing and whether or not the method’s applicability should be modified.

No, there is no quantitative data presented in the manuscript.

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? No, there is no safety section. 2. Does the method contain system suitability tests or controls as specified by the SMPR? If no, please indicate if there is a need for such tests or controls and which ones. No, none were analyzed. The method is qualitative only. 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. No, see above 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. Yes, it is fairly straight forward. 5. Based on the supporting information, what are pros/strengths of the method? It uses a very selective and sensitive instrument, that can do quantitation as well as structural elucidation. 6. Based on the supporting information, what are cons/weaknesses of the method?

No quantitation, no use of standards, etc. 7. Any general comments about the method?

The method needs a lot of work to be advanced as first action.

V.

RECOMMENDATION FOR THE METHOD: 1. Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? If no, please specify rationale.

No, the method does not meet the SMPR requirements.