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?

Yes.

Yes.

Yes.

This method utilizes readily available instrumentation and reagents and gives accurate and reasonably precise results. The HPLC conditions were optimized to give relatively rapid results and the sample preparation steps were simple and straight forward. The method therefore, should be useful for quality testing purposes. The chromatography showed peak tailing and lack of baseline resolution for some of the analyte peaks. Some of the %RSD precision results were high for minor catechins. Use of all of the individual catechin standards This method could be optimized by individual laboratories with minor modifications of chromatographic conditions. Determining relative response factors for the minor catechins might be advisable for routine quality testing work. Yes. The method is appropriate and applicable to routine testing for quality purposes. Additional work may need to be performed to determine the application in supplement forms not addressed in the journal reference: e.g., liquids, soft-gelatin capsules.

7. Any general comments about 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.