SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

A lot of information are missing in the method report:

1) The method did not clearly indicate the analytical ranges of the analytes;

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. D. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. E. Based on the supporting information, what are the pros/strengths of the method?

2) The method did not show in detail how the spike recovery study was performed;

3) Only one point of RSDr% data for flavokavains presented, not at least 2 points as required by the SMPR for different concentration ranges;

4) Only kava extract sample was tested.

IV. General Submission Package

No, the method as written did not show any precaution and warning.

No system suitability test was performed in the method report, and no control is included in the method. A system suitability test must be performed.

Again, the method and the method report did not mention anything about the system suitability test and controls.

This is a method development work report. The method as written is not complete, clear and concise. No standard operation procedures of the method was presented in the report. A lot of supporting data are needed to prove this is a qualified method based on the SMPR.

1) the basic analytical conditions were developed for the analysis of 6 kavalactones and 3 flavokavains as the SMPR required;

2) the method seems working for the analysis of 6 kavalactones and 3 flavokavains in kava extract. The analytical ranges for the analytes were established, and some spike recovery data and repeatability data of the method were reported, although may be not reliable.