81
82
4.
Method Performance Requirements
:
83
Single laboratory
validation
Limit of Quantitation
(LOQ)
1% (w/w)
Analytical Range
1-10% (w/w)
>10-100% (w/w)
Repeatability (RSD
r
)
≤ 3%
≤2%
Recovery
92-105%
98-102%
Multi-laboratory
study
Reproducibility (RSD
R
)
≤ 6%
≤4%
84
85
5.
System suitability tests and/or analytical quality control
86
Suitable methods will include blank check samples, and check standards at the lowest point and
87
midrange point of the analytical range, and a protocol to demonstrate suitability.
88
89
6.
Reference Material(s)
90
Refer to 19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012),
91
Annex F:
Development and Use of In-House Reference Materials
i
Guidelines
92
for Standard Method Performance Requirements.
Available at:
93
94
95
7.
Validation Guidance
:
96
All matrices listed in Annex II must be evaluated for LOQ, repeatability, and recovery for
97
First Action
Official Methods of Analysis
approval.
98
99
Candidate methods should be challenged with materials known to interfere with the assay.
100
101
Guidelines for Collaborative Study Procedures To Validate Characteristics of a
102
Method of Analysis
;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
103
(2012). Available at:
104
105
Guidelines for Dietary Supplements and Botanicals 19
th
Edition of the AOAC
106
INTERNATIONAL Official Methods of Analysis (2012). Also at: . AOAC Int. 95, 268(2012); DOI:
107
10.5740/jaoacint.11-447 and available at:
108
109
ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods of the
110
19
th
edition of the
AOAC INTERNATIONAL Official Methods of Analysis
. Available at
111
112
113
114
8.
Maximum Time-To-Result
:
No maximum time to result.
115
116
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