SPSFAM EXPERT REVIEW PANEL

III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 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

No supporting info attached.

No. method does not provide any data or examples of its ability to meet the accuracy and precision requirements (% recovery, %RSDr or %RSDR), either across the quantitative range, or in beverage samples. It is highly unclear in its sensitivity determination (reported LOD). It did not address blanks, performance across beverage matrices, and it did not follow SMPR procedures for sensitivity/quantitative limit determination. LOD as defined in SMPR is not used and the method does not specify how the reported LOD was determined. LOQ is never mentioned. Accuracy is never assessed or discussed. Details on preparation of a reference material (BPA calibration curves, spiked water) are totally absent. Based on missing all but 1 piece of method performance measures it is impossible to determine if this method is capable of meeting method performance requirements. No. As stated previously, there is only 1 method performance requirement reported (LOD) and it is not clear if SMPR guidelines were followed (3*SD of n=10 blanks). There are some repeatability %RSDs reported, but they are instrumental response variances not sample quantitation variances, they do not span the quantitation range. No (accuracy) recoveries were stated or shown. No LOQ calculated or reported. No reproducibilties (RSD-R) assessed or reported, and nothing done in any of the drink matrices required from Table 3.

no

No the method contains no specified system suitability tests or controls. The SMPR requires negative controls (blanks) and low and mid-point positive controls. This method contained none of those.