AOAC SPIFAN Nutrients ERP Method Reviews (September 7, 2019)

Table 3-12 show the repeatability and intermediate precision for different samples. The repeatability results for these samples meet the SMPR. There is no data supporting the LOD/LOQ. However, based on the Table 1 results, a number of samples have fluoride concentration below 10 ug/100g, which is well below the SMPR requirement of LOQ at 30 ug/100g. The repeatability of the measurements of those low fluoride samples is quite good, indicating excellent sensitivity. IV. General Submission Package 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? * None 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. * This method requires to establish separate calibration curve for each pair of electrodes, and a standard check must be done every 2 hours. The standard check reading must be within 2%. The SMPR requires to have a blank check samples, and two check standards at the lowest point and midrange point. The method could be modified to meet this SMPR. 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. * The system suitability tests work appropriately. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. * Step E. 1. f) and g) needs some clarification. Specifically, what is the total volume approximately? The rest of the method is clear. 5. Based on the supporting information, what are the pros/strengths of the method? * The pros/strength of the method include: 1) It is simple, easy to use method. The sample preparation is simple. The device is easy to operate. 6. Based on the supporting information, what are the cons/weaknesses of the method? * The cons/weaknesses of the method is the potential interference:

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