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).

Yes. The proposed method has been applied for the quantitative analysis of caftaric acid, chlorogenic acid, cynarin, echinacoside, and cichoric acid which are the phenolic compounds indicated in the SMPRs. The used Echinacea matrixes include raw materials (whole and powdered), dietary ingredients (aerial and root extracts) and dietary supplements (tinclure, powders, hard capsules and sof gels) as indicated in the SMPRs.

Yes. The analytical technique used in the method meet the SMPR.

Yes

Yes

III. Review of Information in Support of the Method

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.

Yes. The definitions specified in the SMPR are used and appropriately applied in the proposed method.