SPDS EXPERT REVIEW PANEL

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? F. Based on the supporting information, what are the cons/weaknesses of the method?

Yes

The proposed method refers to previously reported publications (Brow et al., 2010, 2011 & 2016). I think that the obtained results need to be gathered and the proposed method be reformatted from existing publications into a single document. This will enhance the quality of the method and make easier its reading and understanding.

Procedure is well described. Peaks of the obtained chromatographic profiles are well separated.

The proposed method needs to be formatted in a new complete one.

G. Any general comments about the method?

None

Recommendation for the Method

Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

I think that the method ECH-001 is a promising method for the quantitative analysis of the indicated phenolic compounds (caftaric acid, chlorogenic acid, cynarin, echinacoside and cichoric acid) in raw materials, dietary ingrédients and dietary suppléments containing Echinacea. I would then support this method for First Action but would recommend the method to be rewritten and proposed in a more complete form making it easy to read and to understand and where the SMPR requirements will be clearly indicated for each individual phenolic compounds.