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PDE5-001

Are there any safety concerns with

any component, instrument, reagent

or instruction of the method? If yes,

please clearly state the concerns.

No, just the usual safety issues with solvent.

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.

Yes for organic solvents

Recommendations

Final Recommendation:

The submission needs to be made clearer and more

understandable. It is also very hard to see if the POD

model was used, as well as data for all the target and

nontarget compounds in Annex II and II. As it stands

now, the recommendation for first action cannot be

made as it appears the method does not meet SMPR

2014.012 nor SMPR 2014.010 for screening and

identification.