SMPR Key Points: Screening Method
Parameter
Parameter
Requirements
Target Test
Concentration
Minimum
Acceptable
Results
Laboratory Validation
LPOI
Use Appendix N:
ISPAM Guidelines for
Validation of
Qualitative Binary
Chemistry Methods.
low
concentration
≥ 0.85
§
10 x low conc.
≥ 0.95
§
Multi ‐
LPOI
(0)
0 ppm
≤ 0.05
§
§
95% confidence interval
SMPR Key Points: Determination Method
•
Intended Use
: Reference method for dispute
resolution.
•
Applicability
: Quantitative method for PDE5
inhibitors in dietary ingredients and supplements
for use in testing laboratories by trained
technicians.
•
Maximum Time To Result:
No maximum time
‐ ‐
.
