SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

The LOD, LOQ and the analytical range are given in the ug/mL, not the mg/g unit. It is difficult to convert the unit in ug/ml to mg/g since no average tablet weight is provided. Assuming the average tablet weight is 1g, the linear range of 0.6 ug/ml to 632 ug/mL corresponds to 0.12 mg/g and 120 mg/g, which meet the analytical range (5-800 mg/g) and LOQ (1 mg/g), since one can always dilute the solution to the appropriate concentration level. The recovery, repeatability and reproducibility validation data seems all in the >15 mg/g range. But the data looks excellent, they are well within the limits for the larger than 15 mg/g group.

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

The compound is very unstable. It would be nice to recommend the maximum injection number or the total time for each sample queue.

Yes

Yes

Clear and concise. Minor edition: in preparation of samples, the dilution description need to be revised.

Pro: Simple method with common instrument.