SPDS Set 1 ERP Book

PDE5-003

to 1:250 fold). An assumed 0.1g sample weight would have the low range at 500ppm. This is 10x the desired low range (but is based on assumed values). A stated range with supporting data is needed for a complete evaluation. Also, the upper limit is assumed acceptable due to the method's flexibility of the dilution steps. Not stated. Using typical weights, dilutions, etc. as listed in PDE5-003 calculates to 500ppm, but this value is likely neat the middle of the calibration curve.

LOQ:

Accuracy/Recovery

Data not supplied

Precision (RSDr)

Data not supplied

Reproducibility (RSDR)

Data not supplied

System Suitability Criteria to use multiple daughter ions as analyte confirmation is well developed. Many excellent points are listed to assess method accuracy and confirmations. Safety Review Is the method safe to use as written? Safety concerns are listed on page 1 of document T028

Are there any safety concerns with any component, instrument, reagent or instruction of the method? If yes, please clearly state the concerns. Does the method include all necessary safety precautions and/or warning statements? Yes or No. If No, please suggest potential precautions or warnings that can be added to the method for users or recommend safer option(s) if warranted.

The method does address safety concerns.

yes

Recommendations

I do not recommend this method be adopted First Action Status at this time. Review of a complete single lab validation study data is needed to document this methods performance for the stated analytes and matrices. While it is my opinion this method can perform in accordance with the three SMPR requirements, sufficient documentation is needed for First Action Status recognition.

Final Recommendation: