SMPR Key Points: Identification Method
•
Intended Use
: Reference method for dispute resolution.
•
Applicability
: Identification of PDE5 inhibitors in dietary
ingredients and supplements.
•
Identification Method:
A method that is capable of
identifying the PDE5 inhibitors listed in Annex II and
providing at least class identification of other PDE5
inhibitors based on their structural similarity to the
d li t d i A II Th id tifi ti
h ld
compoun s s e n nnex . e en ca on s ou
be done using technique‐specific, generally acceptable
criteria, such as those given in 2002/657/EC.
•
Maximum Time‐To‐Result:
No maximum time.
SMPR Key Points: Identification Method
Parameter
Parameter Requirements
Target Test
Concentration
Minimum
Acceptable
Results
Minimum of 33 replicates
90% POI
§
of
boratory Validation
POI @ low
concentration
representing all target
compounds in Annex II and all
matrix types listed in Annex III,
spiked at or below the designated
low level target test conc.
100 ppm
the pooled
data for all
target
compounds
and matrices
POI @ high
Minimum of 5 replicates per
matrix type spiked at 10x the
10 x low conc
Single La
concentration
designated low level target test
conc.
.
100% correct
analyses are
expected
POI @ zero
concentration
Minimum of 5 replicates per
matrix type.
0 ppm
§
95% confidence interval
