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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
•
Commercially available standards
from Chromadex for 7 OH
•
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
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.
December 9, 2015
KRA-02
Quantification of Mitragynine in
Kratom Raw Materials and
Finished Products by
High-Performance Liquid
Chromatography: Singly
Laboratory Validation
•
LOD and LOQ information for 7-
OH required.
•
Repeatability must be improved
•
More accuracy and recovery data
•
Peak purity PDA
•
Examine additional wavelength
data
December 9, 2015
KRA-03
Identification and Characterization
of Indole and Oxindole Alkaloids
from Leaves of
Mitragyna speciosa
Korth Using Liquid
Chromatography-Accurate QToF
Mass Spectrometry
•
Need precision and accuracy to
demonstrate compliance with the
SMPR.
December 9, 2015
KRA-04
LC/MS Method for the
Identification of Mitragyna
speciose (Kratom) and
•
Feedback on recoveries outside
the SMPR
•
Demonstration of precision data
December 9, 2015
ERP PROFILE SUMMARIES
67