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PDE5-002
ppm.
No time time-to-result information provided.
Overall, not enough information to evaluate the method
performance.
Supporting Data
General Comments
The method was not validated according to the AOAC
2014.012 SMPR for screening of PDE5 inhibitors. Only
method was submitted with minimum method
performance information.
Method Optimization
Evaluate other extraction solvents. Validate the method
according to the AOAC 2014.012 SMPR for screening of
PDE5 inhibitors..
Performance Characteristics
Analytical Range:
No data provided, just information about zone
detectability
LOQ:
Estimated LOD 30 ng/zone (10 ng/μL). Based on the
sample preparation (500 mg sample in 100 mL
methanol), this corresponds to 2 ug/mg (2000 ug/g, 2000
ppm).
Accuracy/Recovery
No data
Precision (RSDr)
No data
Reproducibility (RSDR)
No data
System Suitability
On track 1 of each plate, a mixture of sildenafil,
vardenafil and tadalafil was applied as a system
suitability test.
Safety Review
Is the method safe to use as written?
Yes
Are there any safety concerns with
any component, instrument, reagent
or instruction of the method? If yes,
please clearly state the concerns.
No particular concern.
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
No safety statement is provided. At least a generic
statement should be included, such as:
See AOAC Official Methods of Analysis (2005), Appendix
B: Laboratory Safety. Use appropriate personal
protective equipment such as lab coat, safety glasses,
rubber gloves, and a fume hood. Dispose of solvents and
solutions according to federal, state, and local