SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

No. The method has only been applied for analysis of mix standard solutions. The performance of this method for matrices listed in the SMPR cannot be assessed.

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

No. There is no system suitability tests in the procedure. The method has not been written as per AOAC OMA.

n/a, no system suitability was described.

The procedure states phosphoric acid is used for the preparation of the formic acid solution.

Performance for standards appears acceptable.