SPDS 09052014 - page 147

Table 2: Selectivity Study 70
Parameter Parameter Requirements
Final
Test Concentration Minimum
Acceptable Results
Single Laboratory Validation
Target Test each target compound listed in Annex II at
the final test concentration. Low concentration 100% positive
results**
Non-target
Test each non-target panel compound at the
final test concentration or at the highest
expected matrix concentration in the case of
naturally occurring matrix components. A list
of potential non-target compounds for
immunoassays is provided in Annex III.
10 x low conc. ≥95% negative
results
** 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.
71
5. System suitability tests and/or analytical quality control: 72
The controls listed in Annex I shall be embedded in assays as appropriate. Interference controls should 73
be used for method verification for each new matrix. 74
75
6. Reference Material(s): 76
Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F: Guidelines 77
for Standard Method Performance Requirements; 19th Edition of the AOAC INTERNATIONAL Official 78
Methods of Analysis (2012). Available at:http://www.eoma.aoac.org/app_f.pdf 79
80
7. Validation Guidance: 81
All claimed matrices shall be evaluated (see Annex IV for matrices relevant to the detection of PDE5 82
inhibitors.) Minimum matrices for validation study shall include at least one raw ingredient, such as 83
Epimedium herbal extract and/or powder, and at least one finished product, such as capsules (both 84
the content and the capsule shell). 85
86
Appendix D:Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method 87
of Analysis; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available 88
at:http://www.eoma.aoac.org/app_d.pdf 89
90
Appendix K: Guidelines for Dietary Supplements and Botanicals; 19th Edition of the AOAC 91
INTERNATIONAL Official Methods of Analysis (2012). Available at: 92
http://www.eoma.aoac.org/app_k.pdf 93
94
Appendix N:ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods; 19th Edition 95
of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at 96
http://www.eoma.aoac.org/app_n.pdf 97
98
8. Maximum Time-To-Result: 1 hour 99
100