Development of Matrix Matched Quality Control Materials and Sample Preparation Techniques for the Analysis of Marijuana Infused Products and their Application to Edible Testing

As submitted by the proposer: The local legalization of marijuana within the United States for both medicinal and recreational use has increased. Currently, marijuana is legal in some form in 29 states and the District of Columbia. Marijuana is classified as a Schedule 1 substance by the U.S. Drug Enforcement Agency (DEA). The U.S. Food and Drug Administration (FDA) does not regulate or enforce manufacturing of marijuana or marijuana products other than Marinol®. Marijuana-infused products such as candies or baked goods contain psychoactive cannabinoids tetrahydrocannabinol (THC) and/or cannabidiol (CBD). There is the potential increase in seizures of marijuana products by law enforcement personnel with legalization. The testing results of these products may come into question as a result of limited published data which evaluates the stability of the psychoactive cannabinoids in these matrixes. The Scientific Working Group for Forensic Toxicology (SWGTOX) and FDA guidelines require that samples are analyzed using matrix matched calibrators and quality control materials whenever possible. A previously published LC-MS-MS method for cannabinoid analysis including THC and CBD will be used to evaluate the cannabinoids in these products. Traditional and new sample preparation techniques will be evaluated including: SPE methods, LLE methods, and filtration. Prepared QC materials will be used to evaluate cannabinoid stability under different conditions. Three distinctly different matrices will be prepared; brownies (traditional edible), dark chocolate (high fat content), and gummies (high sugar content), at 5 mg THC & CBD, 10 mg THC & CBD, and 10 mg CBD. They will be vacuum packed to eliminate potential oxidation. Cannabinoid stability at room temperature, refrigerator (5 degrees Celsius), and freezer (-15 & -70 degrees Celsius) and at post-preparation times of initial day, 48 hours, 1 & 2 weeks, 1, 3, 6, 9, & 12 months will be evaluated in triplicate. Data for each prepared QC will be evaluated and the replicate analysis will be summarized and documented with previous results. All data generated will be cataloged by instrument, experiment, and sample type, in laboratory notebooks, either paper or electronic. Results will be presented at annual national meetings, and through publications in peer reviewed journals depending on status of analysis and deadlines for submission. Note: This project contains a research and/or development component, as defined in applicable law, and complies with Part 200 Uniform Requirements - 2 CFR 200.210(a)(14). ca/ncf