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
Parameter Parameter Requirements
Target Test
Concentration
Minimum
Acceptable
Results
oratory Validation
POD @ low
concentration
Minimum of 33 replicates
per matrix type, spiked at
or below the designated
low level target test conc.
100 ppm
90% POD
§
POD @ high
Minimum of 5 replicates
per matrix type spiked at
10 x low conc 100% correct
Single Lab
concentration 10x the designated low
level target test conc.
.
analyses are
expected per
matrix type
POD @ zero
concentration
Minimum of 5 replicates
per matrix type.
0 ppm
§
95% confidence interval
