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Table 1: Method performance requirements
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Type of Study
Parameter
Minimum acceptance criteria
7-OH Mitragynine
Mitragynine
Single-
laboratory
validation
Analytical range
0.01-0.5%
0.1-15%
Limit of quantitation (LOQ)
≤ 0.0005%
(≤ 5 ppm)
≤ 0.0005%
(≤ 5 ppm)
Recovery
0.01% - 0.1%
90-107%
-
>0.1% - 0.5%
95-105%
95-105%
>0.5% - 15%
-
97-103%
Repeatability (RSDr)
0.01% - 0.1%
≤ 5
-
>0.1% - 0.5%
≤ 4
≤ 4
>0.5% - 15%
≤ 3
≤ 3
Multi-
laboratory
Validation
Reproducibility
(RSDR)
0.01% - 0.1%
≤ 8
-
>0.1% - 0.5%
≤ 6
≤ 6
>0.5% - 15%
≤ 4
≤ 4
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