SPDS 09052014

81 82 83

4. Method Performance Requirements :

Limit of Quantitation (LOQ)

1% (w/w)

Analytical Range

1-10% (w/w)

>10-100% (w/w)

Single laboratory validation

Repeatability (RSD r )

≤ 3%

≤2%

Recovery

92-105%

98-102%

Multi-laboratory study

Reproducibility (RSD R )

≤ 6%

≤4%

84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99

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, and a protocol to demonstrate suitability.

6. Reference Material(s)

Refer to 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012), Annex F: Development and Use of In-House Reference Materials in Appendix F : Guidelines

for Standard Method Performance Requirements. Available at:

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

7. Validation Guidance :

All matrices listed in Annex II must be evaluated for LOQ, repeatability, and recovery for

First Action Official Methods of Analysis approval.

100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116

Candidate methods should be challenged with materials known to interfere with the assay.

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). Also at: . AOAC Int. 95, 268(2012); DOI: 10.5740/jaoacint.11-447 and available at: http://www.eoma.aoac.org/app_k.pdf Appendix N : ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods of the 19 th edition of the AOAC INTERNATIONAL Official Methods of Analysis . Available at

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

8. Maximum Time-To-Result : No maximum time to result.

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