SPDS EXPERT REVIEW PANEL

A. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. B. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR. C. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. D. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s).

All six major kavalactones and flavokavains A, B, and C are identified by this method; however complete separation of 2 pairs of kavalactones (K & Y, and DHM & K) was not complete. Not reported are quantitation of individual compounds.

Identification of all six major kavalactones and flavokavains A, B, and C are covered by this method; however complete separation of 2 pairs of kavalactones (K & Y, and DHM & K) was not complete. 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.

They are used appropriately.

Hazards and proper use of dioxane in a mobile phase component must be added.

III. Review of Information in Support of the Method

A. 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.

Definitions are appropriate.