SPDS EXPERT REVIEW PANEL

B. 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. A. 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? B. 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. C. 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. C. Is there information demonstrating that the

No reference material was used in this study.

Reported results do not list quantitation of individual compounds using TLC peak areas; however ratios of corresponding peak areas are listed to identify difference between noble and 2-day kavas. Interestingly, quantitation of individual compounds were not reported even with reported high R2 on calibration curves (note: calibration curves are quadratic). It is therefore not possible to assess method performance against SMPR precision and accuracy requirements.

IV. General Submission Package

Quantitation of the individual compounds was implied but not reported. That information is needed to evaluate method adherence to SMPR.

Standards covering a range of concentrations were used to assess separation on the HP-TLC plates; however separation of 2 pairs of kavalactones (K & Y, and DHM & K) was not complete.

No. Separation of two pairs of kavalactones (K & Y, and DHM & K) was not complete. Quantitation of the separated compounds was not listed but were implied due to discussion on calibration curve linearity.