SPDS 09052014

Analytical Challenges

• Number of potential synthetic PDE5 inhibitors: – more than 100 known analogs – more than 50 analogs reported as adulterants • Availability of reference standards • Inventiveness of adulterators: – exotic analogs i f l – m xtures o ana ogs – embedding of adulterants into capsule walls • Complex and variable dietary supplement matrices

Fitness for Purpose

(1) Screening Method

(2) Identification/Determination Method