SPDS EXPERT REVIEW PANEL

A. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. 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.

Generally: YES: The applicability of the method is adequate to the applicability of the SMPR. Some matrices have been omitted, or their suitable results are not presented in the described method.

YES: The analytical techniques in the method are adequate and meet the SMPR.

YES: Definitions, which are specified in the SMPR, were listed in the description, also were applied appropriately in the method.

Yes: The method contains all appropriate precautions and warnings related to the method’s reagents, components, instrumentation, or method steps that may be hazardous.

III. Review of Information in Support of the Method

YES: The definitions specified in the SMPR were used and applied appropriately in the supporting documentation (appendix 1-6, etc.).

YES: There are information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Material stated in the SMPR.