SPDS 09052014

SMPR Key Points:  Screening Method

• Intended Use : Routine surveillance of dietary  ingredients and products by a trained technician. • Applicability : Qualitative assay for PDE5 inhibitors  in dietary ingredients and supplements.  • Maximum Time‐To‐Result:   1 hour • Non‐Target Compound Panel: Shall be developed  for the selectivity study based on the used  analytical technique.

SMPR Key Points:  Screening Method

Minimum  Acceptable   Results

Target Test  Concentration

Parameter Parameter Requirements

Minimum of 33 replicates  per matrix type, spiked at  or below the designated  low level target test conc.

100 ppm 

POD  @ low  concentration

90% POD §

Minimum of 5 replicates  per matrix type spiked at 

POD @ high 

10 x low conc 100% correct .

oratory Validation

concentration 10x the designated low  level target test conc.

analyses are  expected per  matrix type

Single Lab

POD @ zero  concentration

Minimum of 5 replicates  per matrix type. 

0 ppm

§ 95% confidence interval