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PDE5-004

would be needed as well.

Supporting Data

General Comments

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.

Method Optimization

Not described

Performance Characteristics

Analytical Range:

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.)

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.

There should be statement of safety or precautionary

measures when handling reagents and there are none.

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.

No. Handling of reagents and enzymes need to have

some statement of safety and handling procedure

requirements.

Recommendations