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Definitions are not provided, but they way the terms are used appears to be correct.
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).
No safety notes are provided
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.
They appear to be, but the method is very short.
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.
Anatlytical range not specified for either alkaloid, LOQ not specified for either alkaloid. LOD for
both alkaloids meet SMPR. No spike recovery for 7-OH, spike recovery for Mitragynine is 72-145
% (SMPR is 95-105%, does not meet requirement), Repeatability not reported for either
alkaloid. Reproducibility reported as "less than 4%" for mitragynine (Meets SMPR), not
reported for 7-OH.
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.
A biological reference material extract was used as a positive control
4.
Is there information demonstrating that the method performs within the SMPR Method
Performance Requirements table specifications for all analytes in the SMPR applicability
statement? If no, please specify what is missing and whether or not the method’s applicability
should be modified.
Outlined in section 2
IV.
GENERAL SUBMISSION PACKAGE:
1.
Based on the supporting information, were there any additional steps in the evaluation of the
method that indicated the need for any additional precautionary statements in the method?
There are no precautionary steps. Usual lab precautions should be sufficient.