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Reproducibility
— Statistical variation in the analytical outcome influenced by typical laboratory
47
variables. Replicate analyses are conducted on different days by different operators using different
48
sets of equipment, occasionally in different physical locations. Expressed as the
reproducibility
49
standard deviation
(SD
R
) or
%
reproducibility relative standard deviation
(% RSD
R
).
50
51
Recovery
— The relative percentage of the spiked analyte recovered from a given matrix following
52
implementation of the complete analytical procedure.
53
54
5.
Method Performance Requirements
:
55
See Table 2.
56
57
6.
System suitability tests and/or analytical quality control:
58
Appropriate technique‐specific system suitability criteria will be specified to demonstrate adequate
59
method performance with respect to the claimed analytes.
60
61
7.
Reference Material(s):
62
63
NIST SRM 3398:
Ginger (
Zingiber officinale
) Rhizome
In preparation
64
NIST SRM 3399:
Ginger (
Zingiber officinale
) Extract
In preparation
65
USP Item # 1291504:
Powdered Ginger
$369
66
USP Item # 1291446:
Ginger Constituent Mixture
$369
67
68
Or other reference materials
69
70
Table 1: Commercial Sources of Ginger Constituents.
71
72
Commercially Available Ginger Constituents
Gingerols
Shogaols
Paradols
Zingerone
[6]‐
[8]‐
[10]‐
[6]‐
[8]‐
[10]‐
[6]‐
[8]‐ [10]‐
Chengdu Biopurify
X
X
X
X
X
X
X
Chromadex
X
X
X
X
X
X
Extrasynthese
X
X
X
Phytolab
X
X
X
X
X
X
Sigma‐Aldrich
X
X
X
X
X
X
Tokiwa
X
X
X
X
Dalton Research
X
X
X
X
X
X
X
73
Refer to Annex F:
Development and Use of In‐House Reference Materials
in Appendix F:
Guidelines for
74
Standard Method Performance Requirements
, 19
th
Edition of the AOAC INTERNATIONAL Official
75
Methods of Analysis (2012). Available at:
http://www.eoma.aoac.org/app_f.pdf.76
77
8.
Validation Guidance
:
78
Each
required
analyte and each
claimed
optional
analyte should be evaluated in all
claimed
matrices.
79
For each matrix evaluated, an explicit list of analytes to which validation is applicable should be
80
provided.
81
82
Appendix D
: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of
83
Analysis
;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
84
http://www.eoma.aoac.org/app_d.pdf.
85
86