AOAC SPSFAM PAC ERP

3. Is there information demonstrating that the

The method performance is within SMPR specifications. What is the LOQ for 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. 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

The method abstract and the Introduction contain information that may not be supported by the regulatory agencies in the US and EU when dealing with health claims.

For the method:

It should state that it is to determine "Total PACs as PAC A2".

Method indicates using Proanthocyanidins A2 standard but no CAS Number or supplier is noted.

There is no mention of what control to use and the value to expect.

The linearity, RSD, and recoveries meet the requirement.

Standard preparation needs more explanation. Reagent blanks and Procedure blanks need to be explained. Adding DMAC reagent for the UV/VIS needs more explanation. Standards and reagents stability information is needed.

Method is simple to follow and can be used as a routine quality control procedure in any average laboratory.