SPDS 09052014

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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).

Quantitative method

Method of analysis which response is the amount of the analyte measured either directly (enumeration in a mass or a volume), or indirectly (color, absorbance, impedance, etc.) in a certain

amount of sample.

Repeatability

Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator and repeating during a short time period. Expressed as the repeatability

standard deviation (SD r

); or % repeatability relative standard deviation (%RSD r ).

Reproducibility

The standard deviation or relative standard deviation calculated from among-laboratory data.

Expressed as the reproducibility relative standard deviation (SD R

); or % reproducibility relative

standard deviation (% RSD R ).

Recovery

The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed

using the entire method.

4. Method Performance Requirements :

Analytical range

50 - 200 ppm

Limit of Quantitation (LOQ)

≤ 50 ppm

Repeatability (RSD r )

≤ 20%

Single Laboratory Validation

Recovery

70% to 120% of mean spiked recovery over the analytical range

Reproducibility (RSD R )

≤ 30%

Multi-Lab

Validation

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5. System suitability tests and/or analytical quality control:

Suitable methods will include blank check samples, and check standards at the lowest point and

midrange point of the analytical range.

6. Reference Material(s):

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F : Guidelines for Standard Method Performance Requirements , 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at: http://www.eoma.aoac.org/app_f.pdf