On Tuesday, FDA issued draft guidance for the industry titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” Here’s a link to the guidance document: https://www.fda.gov/media/140319/download
For hemp-derived cannabinoid researchers, the guidance contains a suggested method for calculating delta-9 THC content for intermediates such as solutions and extracts in solutions because a dry-weight calculation for delta-9 THC content is not feasible. Without a science background, it’s difficult for me to gauge whether FDA’s proposed method for determining this calculation is legit or complete nonsense. What do you guys think?
Here’s FDA’s proposed method:
". . . Therefore, FDA recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis or cannabis-derived compounds base the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.
This recommended calculation should not be used for other purposes such as chemistry, manufacturing, or controls. Sponsors should submit documentation regarding the steps of this calculation when they submit the IND.
For a solution-based material (intermediate, in-process material, or final drug product),
Determine the density of the liquid formulation and convert 1 mL of the formulation to mass units (mg).
Calculate water content (in mg) of each active and excipient component present in 1 mL of the formulation.
Sum the water content (in mg) for all components present in 1 mL of the liquid formulation and subtract this amount from the total mass of 1 mL (from step 1). This is the water-adjusted total mass of 1 mL of the formulation.
Calculate the mass, or mg amount, of delta-9 THC present in 1 mL of the liquid formulation.
Calculate the percentage delta-9 THC by dividing the mass of delta-9 THC from step 4 by the total water-adjusted mass in step 3 and multiplying by 100."
I’d say it was probably the least offensive way of calculating “THC on a dry-weight basis”.
it means you can still dilute in ethanol and ship across state lines. so long as you do the “water removal” math and use high proof ethanol.
the rule could have been interpreted as “Throw it in a vac oven, and weigh it when your done”, which would have mede diluting in ethanol or other volatile solvent a fail. MCT would presumably still work.
I guess the bigger question is – will the FDA implement this for non research - eg whatever they want to call hemp derived stuff now.
hemp biomass/flower includes moisture - doesn’t it?
Most tests I see show the moisture content of the e.g. flower material at 12-30%? Do labs remove all moisture before testing? b/c doing so increases thc % by weight…
requiring removal of moisture for d8 edibles… gonna make a few outfits get creative with recipes
They’re on the verge of releasing draft rules for CBD. Just yesterday, FDA submitted its “Cannabidiol Enforcement Policy” draft guidance to the Office of Management and Budget.
Another concerning point that could very well affect the “recreational” hemp-derived cannabinoid industry, FDA said in its draft research guidance linked above that " We note that intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even if the starting materials meet the definition of hemp, may no longer meet the definition of hemp and may be considered a Schedule I controlled substance."
That is especially troublesome because I interpret that to mean even “work in progress”, non-finished products need to maintain the < .3% D9THC threshold.
Could somebody please explain how u calculate which amounts of Acid and solvent you need for your d9 conversion? Example: toluol & iBu3al on 1kg cbdp
thx🙏
What are you trying to say with tolueen x on Triisobutylaluminium with cbdp.
You want to isomerize cbdp to thcp ?
Start writing in a manner we can understand your question