AOAC_SPDS_ERP_-_Set_3

2. 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. 3. 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. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method? 6. Based on the supporting information, what are the cons/weaknesses of the method?

no; Can't find a blank injection of the extraction solvent.

YEYS

YES

fully automated derivatization, as an online post-column derivatization System is used. The method is also applicable to complex dietary supplements like soft-gel capsules containing other plant extracts and a variety of excipients

con: from a practical point-of-view: I would assume that only a few labs will have and use this derivatization system

7. Any general comments about the method?

I think an alternative procedure for off-line derivatization (e.g. with AQC-reagent) should be described.

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.

By voting strictly according to the given SMPR I have to recommend this method, as all requirements are fulfilled with excellent Validation data. From a practical point of view my concerns are that only a few labs may have this online derivatization System from Pickering. I would recommend to include an alternative for this labs. This could be an off-line derivatization e.g. with AQC-reagent, which is quick and fast and stable.