SPDS 09052014 - page 152

Annex III: Non-Target Panel
A suitable non-target panel shall be selected based on the analytical technique.
For non-bioassays: it is expected that an appropriate non-target panel will be developed for the
selectivity study in Table 2 of the performance requirement table.
For a bioassay based on PDE5 inhibitors: natural components/matrices with PDE5 inhibition
activity shall be evaluated, such as extracts/powders of
Tribulus terrestris, Cnidium monieri,
Morinda officinalis, Cuscuta chinensis,
and
Epimedium koreanum.
For immunoassay, structurally similar compounds should be tested, such as the following
examples of compounds that are subcomponents of PDE5 inhibitors, which are provided for
illustration purposes:
2-Pyrimidinecarboxamide
5-pyrimidinecarboxamide
Benzenesulfonyl
Piperazin
Piperazinyl
Piperazinylphenolate
3,6,7,12,12a-hexahydro-2-methyl-pyrazino [1', 2':1,6] pyrido[3,4-b]indole-1,4-dione
Benzenesulfonamide
1...,142,143,144,145,146,147,148,149,150,151 153,154,155,156,157,158,159,160,161,162,...277
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