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 method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 3. Is there information demonstrating that the

Would be ideal to have sources for reference grade amino acids.

It appears that a Beta Alanine, Cysteine or Cystine (not sure what CYS refers to), and Hydroxyproline are missing. It does not appear that the different product types are identified with type. Per the SMPR, powders, tablets, liquids, and capsules should be tested. Accuracy was determined by comparison to another validated method for profile levels. We should discuss if this is an acceptable approach as the SMPR references % recovery which should be based on spiking a known amount of analyte(s).

IV. General Submission Package

It would be good to see accuracy and precision data for the missing compounds.

Yes. There is system suitability but not necessarily control material assessment.

Data not provided.