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PDE5-001
General Comments About the
Method:
The method is miniaturized which allows high
throughput for samples. Sample preparation is easy and
simple. The linearity for the three compounds studied is
excellent, they are linear from 50 to 1000 ppm in the
sample. The consumables are inexpensive. The cost of
the DART itself, compared with other DART instruments
on the market, is reasonable. It would still need a highly
skilled operator for the instrument.
Method Clarity
The method could be a little clearer. Extraction times,
drying times, etc., were not mentioned. The data at the
end of the method could have been organized a lot
better. It was a little difficult to follow. Also, an
explanation of how the RSD's were produced would have
been helpful.
Pros/Strengths
small sample size, easy extraction, use of internal
standards for quantitation, ease of automation, use of
MS/MS for selctivity and sensitivity, low maintenance.
Cons/Weaknesses
Needs the use of a highly skilled operator.
Supporting Data
General Comments
The data is rather confusing in order to find out if the 10
replicates are taken form the same extract or are from 10
different extracts. This will need to be cleared up.
Method Optimization
The method appears to be optimized for three target
compounds not the entire list in the SMPR. There is also
no optimization data for the nontargeted panel.
Performance Characteristics
Analytical Range:
50 - 1000 ppm, unsure if this is applicable when a POD
model is used.
LOQ:
none stated, uses a ratio of target to internal standard
which is 0.100 to be considered positive.
Accuracy/Recovery
There were some recovery studies done, but it is unclear
how they were calculated.
Precision (RSDr)
It is unclear how this was calculated.
Reproducibility (RSDR)
It is unclear how this was calculated.
System Suitability
Does not appear to be addressed.
Safety Review
Is the method safe to use as written?
Yes