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

No.

Authors were not able to validate the method selectivity using the probability of identification model. In the response letter to the CSO of AOAC, authors mentioned their observed percentages were within 3.6% of predicted percentages. However, the 3.6% percentage in method discussion section 3.3 refers to the amount ratio percentage between A-type bond and B-type bond procyanidin standard mixture. This percentage concept is irrelevant to the percentage used in the probability of identification model.

No.

The SMPR requires to evaluate at least 33 samples known to contain Type-A proanthocyanidin and at least 33 samples that contain non Type-A proanthocyanidin. In the submitted method, authors were only able to test cranberry press cake sample in 14 replicates.

IV. General Submission Package

Yes. The safety precautions in operating MALDI-TOP MS might be worth mentioning.

No. This information about the system suitability test was not clearly written in the method. The method did not include the requirement of using a quality control material.

No.

No system suitability tests and controls were used in this method.