72 / 150
Repeatability
48
Variation arising when all efforts are made to keep conditions constant by using the same
49
instrument and operator and repeating during a short time period. Expressed as the
50
repeatability standard deviation (SD
r
); or % repeatability relative standard deviation
51
(%RSD
r
).
52
53
Reproducibility
54
The standard deviation or relative standard deviation calculated from among-laboratory
55
data. Expressed as the reproducibilitystandard deviation (SD
R
); or % reproducibilityrelative
56
standard deviation (% RSD
R
).
57
58
Recovery
59
The fraction or percentage of spiked analyte that is recovered when the test sample is
60
analyzed using the entire method.
61
62
5.
Method Performance Requirements
:
63
See table 3 and 4.
64
65
6.
System suitability tests and/or analytical quality control:
66
Suitable methods will include blank check samples, and check standards at the lowest point
67
and midrange point of the analytical range.
68
69
7.
Potential Reference Material(s):
70
71
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F:72
Guidelines for Standard Method Performance Requirements
, 19
th
Edition of the AOAC
73
INTERNATIONAL Official Methods of Analysis (2012). Available at:
74
http://www.eoma.aoac.org/app_f.pdf75
76
77
8.
Validation Guidance
:
78
79
Data must demonstrate ability to identify and quantitate the free amino acids in Table 1 in
80
the presence of the non-target compounds in Table 5. Interferences with the identification
81
and quantitation of target compounds should be reported in the method.
82
83
Method developers should be able to demonstrate that candidate methods can in fact
84
identify and quantitate minor target compounds in the presence of greater concentrations
85
of other amino acids and their related compounds.
86
87
Appendix D:Guidelines for Collaborative Study Procedures To Validate Characteristics of a
88
Method of Analysis; 19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
89
(2012). Available at:
http://www.eoma.aoac.org/app_d.pdf90
91
Appendix F:Guidelines for Standard Method Performance Requirements; 19
th
Edition of the
92
AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
93
http://www.eoma.aoac.org/app_f.pdf94
95
Appendix K
:
Guidelines for Dietary Supplements and Botanicals, Official Methods of Analysis
96
(2016) 20th Ed., AOAC INTERNATIONAL.
97
98