Expert Review Panel for Dietary Supplements

2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR. 3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used.

Yes

On page 13 there is a confusion how LOD and LOQ is used. The submission states: "Therefore, the limit of quantitation (LOD) of this method was set at the low limits of the analytical range for each target analyte". Only LOQ was defined in the SMPR, as the "minimum content of analyte in the given matrix that can be reliably and precisely quantified....". LOQ can be calculated from the signal to noise ratio or from the standard deviation of the slope of 5 calibration curves (at low concentration).

That definition used in the submission is more like LLOQ, the lowest level of quantitation.

On page 17 "Intermediate precision" was used instead of "Reproducibility"

4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s).

Yes, the submission includes a "Safety" section.

III. Review of Information in Support of the Method

III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference.

The supporting documents (Appendices) don't have definitions.