AOAC SPDS ERP DECEMBER 15, 2017

3. Is there information demonstrating that the

Performance data is not provided for cannabichromenic acid tetrahydrocannabivarin acid due to a lack of available commercial standards.

method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 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? 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 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. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions.

IV. General Submission Package

Should there be language included regarding the sampling/storage/disposal of cannabis materials? Both from a safety and legal perspective.

The method does not include a matrix spike procedure to evaluate the extraction/analytical efficiency. Some type matrix spike should be included either in 'clean' equivalent matrix or sample matrix spike.

Overall the method seems to demonstrate that it worked appropriately with the exception of the two compounds not included. While the supporting data give the general impression that the method is appropriate there are several sections that are incomplete or were only performed on a single varietal.

In sections F.b.7 and F.c.4 it is not clear that the extract should be filtered prior to the dilution preparation.

Section F.a discusses sample preparation but greater detail could be provided to insure the greatest possible homogenization and reduction of cross- contamination between samples. How much sample should be processed to be representative? How should the grinder be cleaned between samples?