Expert Review Panel for Dietary Supplements

II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing. 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. 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). 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 methods tests five product types and the applicability calls for dietary supplement raw materials and finished products. All of the products tested were extracts. It might be good to look at performance in plants and solid oral dosage forms.

Yes. This SMPR specifically required a Folic-C method that meets the method performace requirements.

Yes, the terms are used properly.

Safety precautions are not noted, however, the method does not appear particularly hazardous.

III. Review of Information in Support of the Method

Definittions are applied appropriately

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