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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 that was submitted was for only one product. The applicability is for any
dietary supplement raw material or finished products.
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.
Yes.
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, LOQ was done with standards and not in matrix. Only one ingredient was studied.
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.
There was no supporting documentation submitted. Therefore, it was unable to be reviewed.
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.
Yes, it was very minimal. Only one matrix studied, not enough replicates and/or days per
Appendix K. The method as written is good for only one set of species, not the wide range of
dietary supplements. It also would have an impact upon the reproducibility and repeatability of
the method.