102 / 172
48
49
Limit of Quantitation (LOQ)
.— The minimum concentration or mass of analyte in a given
50
matrix that can be reported as a quantitative result
51
52
Mitragynine
.—(
E
)-2-[(2
S
,3
S
)-3-ethyl-8-methoxy-1,2,3,4,6,7,12,12b-octahydroindolo[3,2-
53
h]quinolizin-2-yl]-3- methoxyprop-2-enoic acid methyl ester. CAS no. 4098-40-2. See figure
54
2 for molecular structure.
55
56
Quantitative method
.— Method of analysis which response is the amount of the analyte
57
measured either directly (enumeration in a mass or a volume), or indirectly (color,
58
absorbance, impedance, etc.) in a certain amount of sample.
59
60
Repeatability
.— Variation arising when all efforts are made to keep conditions constant
61
by using the same instrument and operator and repeating during a short time period.
62
Expressed as the repeatability standard deviation (SD
r
); or % repeatability relative standard
63
deviation (%RSD
r
).
64
65
Reproducibility
.— The standard deviation or relative standard deviation calculated from
66
among-laboratory data. Expressed as the reproducibility relative standard deviation (SD
R
); or
67
% reproducibility relative standard deviation (% RSD
R
).
68
69
Recovery
.— The fraction or percentage of spiked analyte that is recovered when the test
70
sample is analyzed using the entire method.
71
72
5
Method Performance Requirements
73
74
See table 1.
75
76
6
System suitability tests and/or analytical quality control
77
78
Suitable methods will include blank check samples, and check standards at the lowest
79
point and midrange point of the analytical range.
80
81
7
Reference Material(s)
82
83
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F :84
Guidelines for Standard Method Performance Requirements
, 19
th
Edition of the AOAC
85
INTERNATIONAL Official Methods of Analysis (2012). Available at:
86
http://www.eoma.aoac.org/app_f.pdf87
88
ISO Guide 34:2009
General requirements for the competence of reference material
89
producers
.
90
91
Cerilliant or equivalent
92
H-099 7-Hydroxymitragynine, 100 μg/mL
93
H-109 7-Hydroxymitragynine-D3, 100 µg/mL
94
M-152 Mitragynine, 100 μg/mL
95
M-182 Mitragynine-D3, 100 µg/mL
96
97