SPDS Set 1 ERP Book

PDE5-004

would be needed as well. Supporting Data

Multiple dietary supplement matrices need to be evaluated to provide an indication of the false positive/false negative rate. However, given this method measures activity and not concentration, it is a good indicator of the potency of the inhibitor, whereas molecular identification of PDE5 inhibitors that have been altered to escape detection would not provide.

General Comments

Method Optimization

Not described Performance Characteristics

Not described. However, indicated between 2.5 and 25 mg or a pharmacological dose. Concentrations are relative to the IC50 (inhibition concentration) relative to known PDE5 inhibitors (e.g. sildenafil, tadalafil, etc.)

Analytical Range:

LOQ: Accuracy/Recovery

Not described

Precision (RSDr)

Not described

Reproducibility (RSDR)

asdas

System Suitability

Safety Review Is the method safe to use as written? Safety for handling enzymes and solutions was not described

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.

There should be statement of safety or precautionary measures when handling reagents and there are none.

No. Handling of reagents and enzymes need to have some statement of safety and handling procedure requirements.

Recommendations