SPDS 09052014

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

Minimum  Acceptable   Results 90% POI § of the pooled  data for all  target  compounds  and matrices

Target Test  Concentration

Parameter

Parameter Requirements

Minimum of 33 replicates

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. Minimum of 5 replicates per  matrix type spiked at 10x the 

100 ppm 

POI @ low  concentration

POI @ high 

10 x low conc .

concentration  designated low level target test  conc.

100% correct  analyses are  expected

boratory Validation

Single La

POI @ zero  concentration

Minimum of 5 replicates per  matrix type. 

0 ppm

§ 95% confidence interval