SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

The supplied published data supports the LOQ roughly an order of magnitude lower than SMPR requires. Analytical range, recovery, repeatability and reproducibility all meet SMPR requirements; Data from additional studies such as solution stability at different storage conditions and extraction efficiency significantly enhance the value of the method and should make it into the final version of the method.

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.

IV. General Submission Package

No

Considering incomplete resolution of the protopanaxatriols, Rg1 and Re, method could benefit from specifying a minimum resolution requirement

The participants of the interlaboratory study were required to successfully complete system precision (%RSD NMT 5% for replicate standard injections), resolution NLT 1.5 and peak tailing NMT 2. Should the latter be specified, it is suggested to consider adding a decimal to the peak tailing requirement, if not reduce it to NMT 1.5%.

Minor editorializing of the procedure is desirable: e.g., removal of references to notoginseng, clarity with the recommended analytical column, references to kava in the title of Table 5, the mention of a 100-µL volumetric pipet