Microsoft Word - Candidates for 2018 ERP of the Year

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III. Kratom ( Mitragyna speciosa)

Kratom ERP Members Present: Darryl Sullivan, Covance (Chair); Joseph Betz, NIH; Nour Eddine Es-Safi, Mohammed V University in Rabat; Charles Metcalfe, Custom Analytics; Tom Phillips, State of MD; John Spzylka, Mérieux Nutrisciences; Yan-Hong Wang, University of Mississippi

Kratom ERP Members Absent: Christine Casey, FDA; Catherine Rimmer, NIST

AOAC Method #

Manuscript Title

ERP Recommendations on Methods

Consensus

Decision Date

KRA-01

Quantitative and Qualitative Analysis of Mitragynine in Kratom ( Mitragyna speciosa) by GC-MS, LC-MS/MS and UPLC-PDA

December 9, 2015

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Commercially available standards from Chromadex for 7 OH

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Need to see recovery data

Include 7 OH data

Range of quantification must cover whole range from SMPR Precision and accuracy data is needed across entire range of quantification Interest from ERP is in the tandem MS method LOD and LOQ information for 7- OH required. Repeatability must be improved More accuracy and recovery data

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KRA-02

Quantification of Mitragynine in Kratom Raw Materials and Finished Products by

December 9, 2015

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High-Performance Liquid Chromatography: Singly Laboratory Validation

Peak purity PDA

MOTION to accept the requested actions as written for KRA-01, KRA-02, KRA-03, KRA-04. Motion by Szpylka, second by Metcalfe. 7 in favor, 0 opposed, 0 abstain. MOTION PASSED.

Examine additional wavelength data

KRA-03

Identification and Characterization of Indole and Oxindole Alkaloids from Leaves of Mitragyna speciosa Korth Using Liquid Chromatography-Accurate QToF Mass Spectrometry

December 9, 2015

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Need precision and accuracy to demonstrate compliance with the SMPR.

KRA-04

LC/MS Method for the Identification of Mitragyna speciose (Kratom) and

December 9, 2015

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Feedback on recoveries outside the SMPR Demonstration of precision data

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03/12/2018