SPDS 09052014

70

Table 2: Selectivity Study

Final Test Concentration

Minimum Acceptable Results

Parameter

Parameter Requirements

Target

Test each target compound listed in Annex II at the final test concentration.

100% positive results **

Low concentration

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.

≥95% negative results

Non-target

10 x low conc.

Single Laboratory Validation

** 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 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98

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

7. Validation Guidance :

All claimed matrices shall be evaluated (see Annex IV for matrices relevant to the detection of PDE5 inhibitors.) Minimum matrices for validation study shall include at least one raw ingredient, such as Epimedium herbal extract and/or powder, and at least one finished product, such as capsules (both

the content and the capsule shell).

Appendix D : Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of Analysis ; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available

at: http://www.eoma.aoac.org/app_d.pdf

Appendix K: Guidelines for Dietary Supplements and Botanicals; 19 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2012). Available at:

http://www.eoma.aoac.org/app_k.pdf

Appendix N : ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods; 19 th Edition

of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at

http://www.eoma.aoac.org/app_n.pdf

99 100

8. Maximum Time-To-Result: 1 hour