full_book

Repeatability: According to the SMPR and taking into account the studied mitragynine

concentration ranges, RSDr values should be ≤3 which is not the case of those given through

the KRA-02 method.

3. Is there information demonstrating that the method performs within the SMPR Method

Performance Requirements using the Reference Materials stated in the SMPR? If no, then

specify the what is missing and how this impacts demonstration of performance of the method.

A reference material (Mitragynine purchased from Chromadex and qualified using certified

reference material from Cerilliant) was used for method recovery investigation. As indicated

above, two of the three obtained values (105.2, 106.0 and 100.9) were out of the range

indicated by the SMPR table (95-105 %).

4. Is there information demonstrating that the method performs within the SMPR Method

Performance Requirements table specifications for all analytes in the SMPR applicability

statement? If no, please specify what is missing and whether or not the method’s applicability

should be modified.

For the 3 recovery given values, one (100.9 %) fit well in the range indicated in the SMPR table.

IV. GENERAL SUBMISSION PACKAGE:

1. Based on the supporting information, were there any additional steps in the evaluation of the

method that indicated the need for any additional precautionary statements in the method?

The method could be assayed with a MS detection method

2. Does the method contain system suitability tests or controls as specified by the SMPR? If no,

please indicate if there is a need for such tests or controls and which ones.

The method does not contain system suitability tests or controls as specified by the SMPR

which should be done.

3. Is there information demonstrating that the method system suitability tests and controls as

specified in the SMPR worked appropriately and as expected? If no, please specify.

The following general comment is given in the conclusion section “The performance

characteristics are within acceptable ranges according to AOAC Internatinal guidelines for

dietary supplements” but no information demonstrating that the method system suitability

tests and controls as specified in the SMPR worked appropriately and as expected is given.

4. Based on the supporting information, is the method written clearly and concisely? If no, please

specify the needed revisions.

The proposed KRA-02 is given such as a poster not a manuscript. Few details regarding the

sample preparation, extraction, results and discussion are given.

5. Based on the supporting information, what are pros/strengths of the method?

Pros/strengths: Simplicity