SMPR Key Points: Determination Method
ry
Analytical range
50 ‐ 200 ppm
Single Laborato
Validation
Limit of Quantitation (LOQ)
≤ 50 ppm
Repeatability (RSD
r
)
≤ 20%
Recovery
70% to 120% of mean
spiked recovery over the
analytical range
Multi‐Lab
Validation
Reproducibility (RSD
R
)
≤ 30%
Motion
•
Move to accept the Standard Method
Performance Requirements for
Screening
Method for PDE5 Inhibitors
as presented.
