2018 Sugar ERP - Method 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?

No, all precautionary statements are included in the method.

The method does not contain system suitability or analytical QC as outlined in section 6 of the SMPR.

Linearity, retention time repeatability, and peak area repeatability were included in the submission, but specific system suitability tests related to these parameters were not part of the method.

The method is clearly and concisely written.

The method provides enhanced specificity compared with more universal HPLC detectors (RID, ELSD).

Acceptable repeatability for most validated matrices.

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

Submission does not fully address all the elements of the SMPR.

7. Any general comments about the method?

No additional comments.

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 submission requires additional information regarding matrix coverage, potential interferences, and system suitability as outlined in the SMPR to be fully applicable to food products as outlined in the method purpose section. Additional pet and animal feed matrices should also be included to address the enzymatic activity in Table 2 and the validation guidance sections of the SMPR.