Cannabis ERP

CAN-002 Re-submission Review Form

Submission Date

2018-08-08 09:47:28

Name

Christian Sweeney

Email

csweeney@cannabistry.com

Organization

Cannabistry Labs

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

No

Please provide justification for your answer.

First Action Requirements were all addressed, but clarifications need to be made as the work does not appear to match the FAR/SMPR in all cases.

The processing information regarding grinding size in the summary of revisions is acceptable based on the ERP report.

The spiked recovery experiments were carried out on low level plant as requested by the ERP and well characterized standard mixtures were used for spiked recovery on CBDA and THC as requested. Some clarification around the 19.17mg/mL THC solution would be helpful, but not critical. According to the FAR document the spiked recovery levels were meant to be tested at the Low and Mid Range per the SMPR which represents 0.1-1% (Low) and >1-25% (Mid). This submission failed to test spike recovery in the Mid Range for either compound and both CBDA spike levels fell below the Low Range. Because the CBDA samples fell below the low range parameter per the SMPR the recovery values cannot be determined to be within specification. The Recovery values for THC are both within specification for the Low Range. The LOQ study determined the CBD LOQ to be well below the LOQ SMPR of 0.1%. It would be helpful to clarify the spike amount as it is initially referred to as a 0.25ug spike and then later referred to as 0.25ppm. This would suggest a 1mL dilution, but that is not referenced in the method.

The column temperature for the LC method was added as requested.

Based on the First Action Requirements as listed, this addendum does not satisfy the ERP/SMPR requirements.