AOAC SPDS ERP DECEMBER 15, 2017

3. Is there information demonstrating that the

LOQ and Range criteria from table 3 in the SMPR are met. Applicable criteria for Recovery & Repeatability are met for required analytes. Reproducibility data are not presented as this was an SLV.

method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 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?

IV. General Submission Package

No.

Yes.

Yes.

Yes.

This method was optimized with a thorough extraction study and separation conditions. The method has been fully validated (SLV) and data presented confirm that the method produces repeatable accurate results. The time to result is quick, and the method is overall robust.