Initial results from the ongoing stability study show a stable quality profile for THC extract and THC distillate. The currently available data support a retest date of 12 months at 25 °C.
Why stability data is crucial
Reliable information on quality and stability is crucial for the processing of a pharmaceutical active ingredient. It supports the planning of procurement and storage and helps ensure that the active ingredient content and relevant quality parameters remain within the defined specifications over the intended period.
Structure of the ongoing study
Canexis products are stored and tested according to the established stability plan at 25 °C and under accelerated conditions at 40 °C. Testing is performed after 3, 6, 9, 12, 18, 24, and 36 months. Analysis includes THC content, defined degradation products, and, depending on the testing time, other quality parameters such as microbiology.
What the first data show
After six months, the THC extract and THC distillate show a stable profile at 25 °C and 40 °C. The THC content remains within specifications. Minor deviations between measurements are within the range of analytical measurement uncertainty.
Cannabinol (CBN) is considered a relevant marker for the degradation of delta-9-THC. As expected, the CBN content increases moderately, more so at 40 °C than at 25 °C. This trend also remains within the specified requirements at the current testing time.
Exemplary excerpt from the stability study ST-0007 for the active ingredient content of THC distillate under accelerated conditions:
Exemplary excerpt from the stability study ST-0007 for the cannabinol content under accelerated conditions:
Next Steps
Based on the data available so far, a retest date of 12 months at 25 °C has been set. The study will continue as planned. Whether the retest date can be extended at a later date will be decided based on the further fully evaluated and released data.
Get in touch – talk to our team about current retest data, specifications and applications.
