A study to verify that a candidate method can correctly authenticate
Vaccinium
species in
42
materials specified in the Authenticity Panel.
43
44
Dietary Ingredients
45
A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use
46
by man to supplement the diet by increasing total dietary intake; or a concentrate,
47
metabolite, constituent, extract, or combination of any of the above dietary ingredients
48
49
Dietary supplements
50
A product intended for ingestion that contains a "dietary ingredient" intended to add
51
further nutritional value to (supplement) the diet. Dietary supplements may be found in
52
many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.
53
54
Selected
Vaccinium
species
55
Vaccinium
species identified by the AOAC Anthocyanins Working Group that are the focus of
56
methods for authentication by anthocyanin profile. See Annex I.
57
58
4.
Method Performance Requirements
:
59
60
Selectivity Study
100% correct identification of all the Authenticity
panel Annex II) materials in the presence or absence of
Exclusivity (Annex III) materials.
*
*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.
61
5.
System suitability tests and/or analytical quality control:
62
63
Methods will include a protocol to demonstrate resolution sensitivity and repeatability.
64
65
6.
Reference Material(s):
66
Refer t
Development and Use of In-House Reference Materials
in Appendix F:
67
Guidelines for Standard Method Performance Requirements
, 19
th
Edition of the AOAC
68
INTERNATIONAL Official Methods of Analysis (2012).
69
70
7.
Validation Guidance
:
71
Guidelines for Dietary Supplements and Botanicals
, 19
th
Edition of the AOAC
72
INTERNATIONAL Official Methods of Analysis (2012).
73
74
Guidelines for Collaborative Study Procedures To Validate Characteristics of a
75
Method of Analysis
, 19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
76
(2012).
77
78
Method developers must submit validation data for all of the species and forms listed in
79
Annex II and Annex III for First Action Official Methods consideration.
80
81
8.
Maximum Time-To-Result:
82
No maximum time to result.
83
84
FDA.
