AOAC SPDS Set 2 ERP

The method does not contain the method performance requirements stated in the AOAC SMPR 2015.008 single laboratory requirements. As stated earlier, the method is qualitative but the requirements are for a quantitative method. The method can be modified to include a calibration curve and the requirements in table 1 could be meet. One significant drawback is the ability of other laboratories to perform the method due to the requirement of a QTof or Orbitap. If a laboratory could demonstrate the separation, maybe the method could be transferred to a PDA. 7. Any general comments about the method? Overall, this method addresses the main issue of analytical separation and identification of 7- hydroxy mitragynine, mitragynine, and 11 other indole alkaloids. If quantitation is important for the SMPR 2015.008, the method can be modified. RECOMMENDATION FOR THE METHOD: 1. Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? If no, please specify rationale. I would overall recommend this method with the few comments I have mentioned in the above sections. Per the AOAC SMPR 2015.008, Table 1method performance requirements, the method would require some additional analysis to determine the analytical range , LOD, LOQ, recovery, and repeatability.

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