Expert Review Panel for Dietary Supplements

3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method? 6. Based on the supporting information, what are the cons/weaknesses of the method?

The method doesn't contain system suitability tests.

Yes. The method contains blank check samples, lowest point check standard (MRL), and midrange point check standard (LCS) for each run sequence.

Authors need to disclose the formulation information of control material, mixture A, and mixture B.

The method is clearly written and generally easy to follow. Most validation experiments were designed based on the SMPR and most SMPR requirements were successfully met.

Authors are recommended to demonstrate the rationales behind the selection of target peptides. Normally, the bottom up shotgun protein identification needs to use software and database for data processing and interpretation. The whole peptide profile is used instead of picking 3 specific peptides.

Authors are recommended to provide more supporting information such as retention time, MS chromatogram, and mass spectrum for each target peptide.

7. Any general comments about the method?

Despite minor flaws that listed before, this method generally met SMPR 2016.015 requirements.

Recommendation for the Method

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

Yes. Despite minor flaws that listed before, this method generally met SMPR 2016.015 requirements and therefore is recommended to be adopted as a First Action Official Method after all recommended supporting information can be provided by authors.