SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

No. The performance of the method has been established for red ginseng but there is no data for the other types of ginseng materials that was in the ERP. It is unknown how valid the accuracy data is given the method that was used. A spike recovery study whereby standards were spiked into powder and concentrate material was performed but the manuscript does not explain how the original amount of each ginsenoside was established. It is also unknown why the levels of the ginsenosides in the powder and concentrates determined in the precision study was different from the levels reported in the accuracy study as the chemicals and reagents section only identify one lot of powder and one lot of concentrate being used in the validation study.

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?

IV. General Submission Package

no

no

no system suitability tests performed

No. The method is not written in AOAC OMA format.

The method appears have acceptable performance parameters for red ginseng but its performance with other sample types has not been evaluated.