SPDS EXPERT REVIEW PANEL

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 method was not attached to the review. The research paper described the broader explanation of the standard and sample preparation but need more detailed step by step instruction.

The method was not attached for review. However, there were no definitions listed in the paper.

There were no safety precautions listed in the paper

III. Review of Information in Support of the Method

There were no definitions described in the paper.

The analytical techniques used in the method lacked some of the criteria. Although the validation scrutinized accuracy, precision, LOD, LOQ and linearity, the specificity and ruggedness of the methods were not clearly presented. The chromatogram showed many close eluting peaks in the sample matrix. Although the paper stated that the peaks were well resolved, it would be easy to misidentify peaks if the testing laboratory did not have right type of reference standards to compare against. Additionally, the system seems very sensitive to gradient program and the concentration of the phosphoric acid in the mobile phase. Under different circumstances, some of the peaks may not be separated. Hence the ruggedness of the method may be questionable. The precision results evaluated from inter and intra day also seem to add to this variability especially with Red Ginseng Concentrate with RSD differing significantly with higher concentration data ( i.e. G-Rg1 at concentration of 2.26mg has 1.11%RSD for intra and 8.84% for inter).