SPDS EXPERT REVIEW PANEL

B. 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. C. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. D. 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). A. 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. B. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method.

Yes, the analytical technique used meets the SMPR.

The definitions specified in the SMPR were used and applied. But the LOQ and LOD were obtained by theoretical calculation, not by experimental determinations, and the SLV report did not specify how the spike recovery data were obtained.

The method as written is not a complete Standard Operation Procedures (SOP), and does not include any precautions and warnings. If the method is accepted as the first action, the SOP should include appropriate precautions and warnings.

III. Review of Information in Support of the Method

The definitions specified in the SMPR were used and applied. But the LOQ and LOD were obtained by theoretical calculation, not by experimental determinations, and the SLV report did not specify how the spike recovery data were obtained.

Yes, very clearly indicated.