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). 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. 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.

The SMPR listed range for the kavalactones is 5 - 750 mg/g. This method has an upper range of 625 mg/g, but I think this is a non-issue.

Analytical technique satisfies SMPR.

Method satisfies SMPR

Cautions list acetonitrile and methanol as flammable but not isopropanol. No statement regarding formic acid.

III. Review of Information in Support of the Method

Yes

Method states the source of Desmethoxyyangonin was from Cerilliant, which is not listed on the SMPR. However this compound is available from them.