Cannabis ERP

CAN-001 Comments – Chris Hudalla - Use of laboratory blender to powderize cannabis flower: Blender type homogenization damages product and ruptures trichomes, unless cryogrinding is employed. A more gentle grinding or sieve grinding method should be considered if cryogrinding is not available. - The term “Oils” as used multiple times in this documents is vague. Is it meant to signify the oil extracted from the plant (which would be a concentrate)? Is it flower that is extracted with, or concentrate that is subsequently dissolved in an oil, like hemp seed oil or coconut oil? If it is this latter definition, there is no mention of the potential for matrix interferences, which often co- elute with cannabinoid signals, interfering with quantitation by UV methods. For UV quantitation, the UV spectrum for a collected peak should be matched against a library reference spectrum to ensure peak purity. The same issues may arise in the analysis of food or other complex matrices. - For cannabis oils, many regulatory requirements include reporting concentration in terms of mg/unit, which for liquids (oils), is typically in mg/mL. Would recommend adding in a density calculation. Maybe instead of weighing out 0.5g, use a glass syringe to or positive displacement pipette to weigh out 0.5mL of oil. Use the recorded weight in the measurement for weight percent, but based on density, can also report mg/mL. All other prep for these samples would remain the same. - Has extraction efficiency of ethanol been evaluated against other options? Isopropanol? More non-polar solvents tend to have higher efficiency in extracting cannabinoids. - Validation activities appear to be fairly comprehensive, hitting all the key elements of a robust validation.