SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

Yes

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. A. 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? B. 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. C. 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. D. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. E. Based on the supporting information, what are the pros/strengths of the method?

IV. General Submission Package

NO

There were no system suitability criteria listed in the supporting research paper. Due to the numerous number of actives this method is intending to analyze, system suitability requirement including the resolution of critical pair is absolutely required in addition to tailing factor and plate count.

No. There is no information in the paper regarding the system suitability criteria or demonstration.

Method was not available for review.

The short run time using UPLC; Improved peak shape with use of Phosphoric Acid; Low detection level.