Expert Review Panel for Dietary Supplements

2. 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. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the

Authors did not provide clear information on the reference materials that they used for establishing LCMS/MS transition parameters.

Yes and no. The POI evaluation of the validation studies has met the minimum acceptance criteria in the method performance requirement table. However, melamine, surfactants, peptides, and nontarget proteins were not evaluated as potential adulterants in the selectivity study.

IV. General Submission Package

Authors did not provide any supporting information for demonstrating the safety of using this method.

The method doesn't contain system suitability tests. System suitability is recommended to use to evaluate if other brand or model of HPLC-triple quad mass detector can be suitable for running this method. Mass accuracy and relative responses of pseudomolecular ion isotopes may be tested to evaluate system suitability. The method used control material for each run. However, authors need to provide the detailed formulation and source of this control material. Also, the quality control criteria of using the control material needs to be clarified.