SPDS 09052014

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Qualitative assay

A method of analysis with two possible outcomes.

PDE5 Inhibitors

For the purposes of this SMPR: PDE5 inhibitors are defined as avanafil, lodenafil carbonate, mirodenafil, sildenafill, tadalafil, udenafil, or vardenafil; or any of their analogs. Refer to the Supplemental List of Known PDE5 Inhibitors (as of July 2014) at the AOAC website (address and

hyperlink to be inserted).

Selectivity Study

A study designed to demonstrate that a candidate method does not detect non-target compounds, and at the same time, demonstrate a candidate method’s ability to detect the different types of

PDE5 inhibitors (as a minimum the target panel provided in Annex II).

4. Method Performance Requirements : Table 1: Matrix Dependent Criteria

Target Test Concentration

Minimum Acceptable Results

Parameter

Parameter Requirements

Minimum of 33 replicates per matrix type, spiked at or below the designated low level target test concentration. Minimum of 5 replicates per matrix type spiked at 10x the designated low level target test concentration.

POD @ low concentration

100 ppm

90% POD §

POD @ high concentration

10 x low conc.

100% correct analyses are expected per matrix type ‡

Single Laboratory Validation POD @ zero concentration

Minimum of 5 replicates per matrix type.

0 ppm

low concentration

≥ 0.85 §

Use Appendix N: ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods.

LPOD

≥ 0.95 §

10 x low conc.

Multi -Laboratory Validation LPOD (0)

≤ 0.05 §

0 ppm

Note: LPOD and LPOD (0)

are not required for Single Laboratory Validations.

‡ 100% correct analyses are expected. Some aberrations may be acceptable if the aberrations are investigated, and acceptable explanations can be determined and communicated to method users. § 95% confidence interval

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