Cannabis ERP

CAN-002 Re-submission Review Form

Submission Date

2018-08-13 06:45:17

Name

Holly Johnson

Email

hjohnson@ahpa.org

Organization

American Herbal Products Association

Has the resubmitted method CAN-002 met the requirements outlined on December 15, 2017?

Yes

Please provide justification for your answer.

Revisions were made as per the ERP recommendations for First Action:

1. Grinding size: • Particle size was determined t be less than 0.5mm. 2. Spike Recovery:

• Additional spike recovery studies were performed with CBDA and THC at 2 levels each, a low and mid-range spike. Recovery was calculated within acceptable ranges as per the SMPR, except for the lowest level spike of CBDA which was spiked at 0.006% (w/w); no recovery parameters were given in the SMPR for spike levels under 0.1%. 3. Redo LOQ study for CBD: • LOQ study was redone specifically for CBD using a low CBD strain. LOQ was determined at 0.04% (w/w) which is below the SMPR requirement of 0.1%. 4. Column temperature was clarified at 25C, as requested.