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 ‐ ‐ .