PDE5 Inhibitors
48
For the purposes of this SMPR: PDE5 inhibitors are defined as avanafil, lodenafil carbonate,
49
mirodenafil, sildenafill, tadalafil, udenafil, or vardenafil; or any of their analogs. Refer to the
50
Supplemental List of Known PDE5 Inhibitors
(as of July 2014) at the AOAC website (address and
51
hyperlink to be inserted).
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53
Quantitative method
54
Method of analysis which response is the amount of the analyte measured either directly
55
(enumeration in a mass or a volume), or indirectly (color, absorbance, impedance, etc.) in a certain
56
amount of sample.
57
58
Repeatability
59
Variation arising when all efforts are made to keep conditions constant by using the same
60
instrument and operator and repeating during a short time period. Expressed as the repeatability
61
standard deviation (SD
r
); or % repeatability relative standard deviation (%RSD
r
).
62
63
Reproducibility
64
The standard deviation or relative standard deviation calculated from among-laboratory data.
65
Expressed as the reproducibility relative standard deviation (SD
R
); or % reproducibility relative
66
standard deviation (% RSD
R
).
67
68
Recovery
69
The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed
70
using the entire method.
71
72
73
4.
Method Performance Requirements
:
74
75
Single Laboratory
Validation
Analytical range
50 - 200 ppm
Limit of Quantitation (LOQ)
≤ 50 ppm
Repeatability (RSD
r
)
≤ 20%
Recovery
70% to 120% of mean spiked
recovery over the analytical range
Multi-Lab
Validation
Reproducibility (RSD
R
)
≤ 30%
76
5.
System suitability tests and/or analytical quality control:
77
Suitable methods will include blank check samples, and check standards at the lowest point and
78
midrange point of the analytical range.
79
80
6.
Reference Material(s):
81
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Guidelines
82
for Standard Method Performance Requirements
, 19
th
Edition of the AOAC INTERNATIONAL Official
83
Methods of Analysis (2012). Available at:
84
85
