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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.
n/a, no CRM's listed for the plant product. Standard's only. One source of a standard is
Chromadex.
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.
No, the LIB does not cover the other ranges as far as repeatability and recovery.
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?
Yes, there was no safety section.
2.
Does the method contain system suitability tests or controls as specified by the SMPR? If no,
please indicate if there is a need for such tests or controls and which ones.
No, only mitragynine was analyzed in the "in-house" reference material. The mitragynine was
quantitated by HPLC-DAD and not with the other techniques in the LIB. The material was not
fully characterized.
3.
Is there information demonstrating that the method system suitability tests and controls as
specified in the SMPR worked appropriately and as expected? If no, please specify.
Yes and no, mitragynine was used solely. 7-OH mitragynine was not quantitated in the
products.
4.
Based on the supporting information, is the method written clearly and concisely? If no, please
specify the needed revisions.
Yes, it is fairly straight forward
5.
Based on the supporting information, what are pros/strengths of the method?
Multiple techniques, GC-MS, HPLC-PDAD, and HPLC-MS/MS. Uses small sample size. With more
sensitive instruments that are now available, it would be possible to analyze at lower ranges.
6.
Based on the supporting information, what are cons/weaknesses of the method?
No data for the lower ranges. It is unsure if the LOD and LOQ have been met, since spikes were
not done.