As licensed producers, your utmost priority is the safety and effectiveness of your product for patients and consumers. Cannabis products with accurate expiration dates are essential for providing consumer assurance that the product is high quality, contains the potency or cannabinoid/terpene profile as per the label claim, and is safe to consume.
What is a stability study?
A stability study is an examination of a substance or product over a specified period of time to examine the effects of different storage conditions on the characteristics of this substance or product. This test essentially identifies the product or substance’s expiration date.
Eurofins EnvironeX is a GMP accredited cannabis contract testing lab. We have level two stability chambers available to initiate stability studies for bulk, finished dried cannabis products, capsules, and cannabis oil products.
Using ICH guidelines we recommend the following conditions, time points and testing parameters to include in your cannabis product stability study
Conditions and Time Points
- Ambient condition – 25oC/65%RH – 24 months (0,3,6,9,12,18,24)
- Accelerated condition 45oC/75%RH – 6 months (0,3,6)
- 5oC – 24 months (0,3,6,9,12,18,24)
- Cannabinoid profile
- Terpene profile
- Loss on Drying
- Microbiology (Dried Product) – TYAM, TAPC, BTGNB, Salmonella and E.coli
- Microbiology (Oil Product) – TYAM, TAPC, BTGNB, Salmonella and E.coli, pseudomonas, staphylococcus
- Rancidity/Oxidation Stability indicating tests for oils
- Peroxide Value
- Acid Value
- Fatty Acid Profile
- P-Anisidine Value