AOAC SPSFAM PAC ERP

2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. 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. 3. Is there information demonstrating that the

Yes

Yes RSDr of the method is <7 meeting the SMPR Recovery is 98.7 to 101.9 in placebo cranberry juice The LOQ of epicatechin was 1.2  g/mL and A2 was 2  g/mL which meets the requirements, however the LOQ was determined in calibration solutions rather than in the matrix.

IV. General Submission Package

No

Yes

Yes