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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.
LOQ:
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.
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.
The method does address safety 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.
yes
Recommendations
Final Recommendation:
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.