AOAC SPDS Set 2 ERP

2. Does the analytical technique(s) used in the method meet the SMPR? If no, please specify what how it differs from what is stated in the SMPR.

The analytical technique does separate and confirm identity of 7-hydroxy mitragynine, mitragynine, and other relevant indoles of Mitragynine speciose, as stated in question 1. The method is not quantitative per the AOAC SMPR 2015.008.

3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used.

Most of the definitions specified in the SMPR are appropriate in this method. Since the method is not quantitative specific definition did not apply for this method such as repeatability and reproducibility. 4. Does the method, as written, contain all appropriate precautionary and warning related to the method’s reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s).

III.

REVIEW OF INFORMATION IN SUPPORT OF THE METHOD: 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc…)? If no, please explain differences and if the method is impacted by the difference.

Yes

2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements table? If no, for any of the parameters in the SMPR Method Performance Requirements table, then please explain what is missing and the impact on performance of the method. There is no information demonstrating the requirements in table 1. Again, the method is qualitative be design hence, the parameters for the single-laboratory validation does not apply. The method stills perform well for the stated purpose of the qualitative work. The method could be quantitative with the addition of a calibration curve. 3. Is there information demonstrating that the method performs within the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If no, then specify the what is missing and how this impacts demonstration of performance of the method. The method does use reference materials. Due to the expertise of the authors in natural product analysis, the researchers were able to isolate individual indoles and oxindole. This