Stability Testing for Cannabis Products

Understanding the stability profile of a product, whether a consumer packaged good or a pharmaceutical drug product, is key to ensuring the consumer has a safe and effective product. In international and Canadian Cannabis Regulations, there are requirements to have data to demonstrate that the potency is maintained within the proscribed range of label claim and microbial and chemical contaminant limits remain within release specification requirements.

MediPharm Labs is a Canadian company based in Barrie, Ontario, focused on producing high-quality cannabis extracts and cannabis derivatives for Canadian and international markets. Loyalist College and MediPharm Labs have been collaborating on applied research projects since 2019. Their four-year strategic alliance supports education, training, development and applied research projects in collaboration with the College’s Cannabis Applied Science post-graduate program.

MediPharm Labs initiated stability studies of some of its products. Establishing the stability of consumer products is paramount to ensuring a safe and effective product reaches the consumer.

To enhance future stability protocols and design better formulations and/or container closures, a deeper understanding of degradation pathways and appropriate stability-indicating assays would be beneficial. The body of scientific literature in this area has been limited due to the regulatory restrictions that have existed with regards to cannabis and its derivatives.

Through the Centre’s collaboration with MediPharm, our research helped provide a better understanding of the stability of active cannabis ingredients, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), which experience degradation when exposed to light, heat and/or oxygen, in relation to real use exposure and storage conditions. Cannabis products are part of an emerging market and there is a need for reliable data to determine the stability of cannabis extracts, oils, edibles and topicals. By establishing reliable expiry dating and optimal storage methods, consumers can be assured product efficacy is accurately represented on label claims.

This initial project was supported through two Mitacs Accelerate funding awards totalling $30,000 and allowed the Centre to hire two interns for six months.

The latest project funded by the Centre’s ARTP COLLABORATE program will evaluate the suitability of a technological methodology to isolate THC of pharmaceutical purity from the distillate input, and will also make recommendations on scale-up to commercial processing.