Microsoft Word - Candidates for 2018 ERP of the Year

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Kratom Expert Review Panel:   Method Reviews and Decisions

Manuscript Title, Submitter and  Reviewers  Title:   Determination of Mitragynine in  Mitragyna speciosa Raw Materials and  Finished Products by Liquid  Chromatography with UV Detection:  Single‐Laboratory Validation  Author(s): Elizabeth Mudge, BCIT; Paula  Brown, BCIT  Submitted by: Elizabeth Mudge, BCIT  Primary Reviewer:   John Szpylka,  Mérieux NutriSciences  Secondary Reviewer:   Christine Casey, US  FDA 

ERP Decisions / Consensus 

AOAC  Method # 

MOTION to move this method to First Action Official  Methods of Analysis ® Status (Casey/Betz)  

10 in favor, 0 opposed, 1 abstentions.  The motion passed. 

Reasoning/Summary:   Robust, accurate method which meets AOAC SMPR  2015.008.  Final Action Requirements:   Adjust calibration curve for standard purity   Details of spiking in the solid samples   Evaluate LOD and LOQ by spiking clean, blank material;   Provide concentrations table   Clarify HORAT 

KRA‐002

13 

03/12/2018