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.

No. This method has been developed and assessed for Korean Red Ginseng powders and concentrates. Red ginseng has undergone steaming and drying processes. The method has not been evaluated for its performance in the analysis of the sample types identified in the ERP.

There was no specified analytical technique in the SMPR.

yes

yes

III. Review of Information in Support of the Method

yes

No. This method has only been evaluated for its ability to analyze red ginseng root. There is no data to establish the method's performance for ginseng material other than red ginseng root. The levels of malonyl ginsenosides in the unprocessed or minimally processed ginseng samples are higher than in red ginseng and these compounds have been shown to affect the precision and accuracy of analytical results.