Expert Review Panel for Dietary Supplements

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?

See answer to question IV. 2

Yes

- The method quantifies not just the required analytes, but four of the optional analytes too.

- All the matrices listed in the SMPR were tested

- The HPLC method is short, and can be easily converted into LC-MS method

- Different extraction methods were investigated and optimized

- Sample preparation is not complicated

- Large amount of validation data