AOAC SPDS Meeting Book March 19 2015

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Table 1: Method performance requirements

Minimum acceptance criteria

Type of Study

Parameter

7-OH Mitragynine

Mitragynine

Analytical range

0.01-0.5% ≤ 0.0005% (≤ 5 ppm)

0.1-15%

≤ 0.0005% (≤ 5 ppm)

Limit of quantitation (LOQ)

0.01% - 0.1%

90-107%

-

Recovery

Single- laboratory validation

>0.1% - 0.5%

95-105%

95-105%

>0.5% - 15%

-

97-103%

0.01% - 0.1%

≤ 5

-

Repeatability (RSDr)

>0.1% - 0.5%

≤ 4

≤ 4

>0.5% - 15%

≤ 3

≤ 3

0.01% - 0.1%

≤ 8

-

Multi- laboratory Validation

Reproducibility (RSDR)

>0.1% - 0.5%

≤ 6

≤ 6

>0.5% - 15%

≤ 4

≤ 4

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