SPDS 09052014
SMPR Key Points: Screening Method
Minimum Acceptable Results
Parameter Requirements
Target Test Concentration
Parameter
low concentration
≥ 0.85 §
Use Appendix N: ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods.
LPOI
10 x low conc.
≥ 0.95 §
Laboratory Validation
LPOI (0)
0 ppm
≤ 0.05 §
Multi ‐
§ 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 ‐ ‐ .
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