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

Method itself does not contain system suitability or criteria. Appropriate tests/criteria should be added to method.

System suitability was noted in the validation, but testing was not performed as described as in SMPR. Would like to see a blank check and standard checks in method.

Mostly. Would like to see detailed information regarding # of standard injections and sequence of injections if it can impact results.

Method is accurate, precise and fairly easy to perform. Especially for these analytes that have been historically problematic.