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II.
REVIEW OF THE METHOD ONLY:
1.
Does the applicability of the method support the applicability of the SMPR? If no, please explain
what is missing.
No, the method is for identification and structural elucidation only. There was not quantitation
done.
2.
Does the analytical technique(s) used in the method meet the SMPR? If no, please specify what
how it differs from what is stated in the SMPR.
A qualified No. With more work it could have met the quantitation requirements.
3.
Are the definitions specified in the SMPR used and applied appropriately in the method? If no,
please indicate how the terms are used.
No, there was no discussion of supplements, LOD, LOQ, etc.
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, there is no safety section.
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.
No, Please see above.
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.
No, there is not repeatability, recovery, LOD, or LOQ data presented. It is qualitative data only.
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.
No, no isotopically labeled standards were used.