60 / 120
Reproducibility
41
The standard deviation or relative standard deviation calculated from among-laboratory data.
42
Expressed as the reproducibility standard deviation (SD
R
); or % reproducibility relative standard
43
deviation (% RSD
R
).
44
45
Recovery
46
The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed
47
using the entire method.
48
49
Dried Plant Materials
50
Dried whole or milled flower plant material from
Cannabis sativa
and its hybrids.
51
52
5.
Method Performance Requirements
:
53
54
See table 2 and 3.
55
56
6.
System suitability tests and/or analytical quality control:
57
Suitable methods will include blank check samples, and check standards at the lowest point and
58
midrange point of the analytical range.
59
60
7.
Reference Material(s):
61
62
See tables 1A and 1B for sources of reference materials.
63
64
Refer to Annex F:
Development and Use of In-House Reference Materials
in Appendix F:
Guidelines
65
for Standard Method Performance Requirements
, 19
th
Edition of the AOAC INTERNATIONAL Official
66
Methods of Analysis (2012). Available at:
http://www.eoma.aoac.org/app_f.pdf67
68
8.
Validation Guidance
:
69
70
Method performance should be demonstrated with homogeneous samples. Inherent variation in
71
the plant may preclude or limit homogeneity for the following reasons: (a) they are resinous,
72
cannabinoids are concentrated in the resin, which can clump during grinding; (b) between flower
73
variation can be high, grinding multiple flowers can impact the homogeneity; (c) grinding can
74
introduce heat, which will cause degradation of cannabidiolic acids into neutral forms, resulting in
75
less accurate results. Grinding would be the best option for homogeneous samples, but in some
76
cases there are issues with clumped resin, highly variable samples and additional grinding would
77
impact the results and lead to inaccurate data.
78
79
Appendix D
: Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method
80
of Analysis;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available
81
at:
http://www.eoma.aoac.org/app_d.pdf82
83
Appendix F
: Guidelines for Standard Method Performance Requirements; 19
th
Edition of the AOAC
84
INTERNATIONAL Official Methods of Analysis (2012). Available at:
85
http://www.eoma.aoac.org/app_f.pdf86
87
Appendix K
: Guidelines for Dietary Supplements and Botanicals; 19
th
Edition of the AOAC
88
INTERNATIONAL Official Methods of Analysis (2012). Available on line at:
89
http://www.eoma.aoac.org/app_k.pdf90
91