SPDS Set 1 ERP Book

PDE5-002

ppm. No time time-to-result information provided. Overall, not enough information to evaluate the method performance. Supporting Data 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. Evaluate other extraction solvents. Validate the method according to the AOAC 2014.012 SMPR for screening of PDE5 inhibitors.. Performance Characteristics

General Comments

Method Optimization

No data provided, just information about zone detectability

Analytical Range:

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).

LOQ:

Accuracy/Recovery

No data

Precision (RSDr)

No data

Reproducibility (RSDR)

No data

On track 1 of each plate, a mixture of sildenafil, vardenafil and tadalafil was applied as a system suitability test. Safety Review

System Suitability

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. 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 particular concern.

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