SPDS EXPERT REVIEW PANEL

C. Is there information demonstrating that the

This method fulfills the SMPR requirements.

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

Flammability for the isopropanol and corrosiveness of the formic acid

I did not see the use of a control or blank check sample.

There is a system suitability statement regarding the precision of a mixed standard solution. I assume this is used as a check standard. No mention of the concentration of this and is the only one mentioned. The SMPR mentions a check standard at the low and mid-range points.

see section B

Excellent method and SLV

Excellent range and sensitivity. Simple sample prep and fast analysis time.