Stability Testing
Knowing the shelf-life of your products is extremely valuable. We use stability testing to determine shelf-life and product efficacy over time—such as how a product degrades and how well the packaging protects the product. This will tell you how long your products will last, what storage conditions are optimal, and how a product’s potency, for example, will change over time. We store your finished product under controlled temperature and humidity, then we test it at various time points depending on needs—say 3, 6 , 9, 12, 18, and 24 months. At each time interval, we test for potency, terpenes, microbials, mycotoxins, and water activity. In addition, cartridges are tested for heavy metals at each timepoint.
Why is Stability Testing Important?
As products degrade over time, they lose efficacy, and can even become harmful in extreme cases. Using accelerated stability studies, we can collect excellent data under controlled conditions over a short period of time that will help to reveal shelf-life of a product and exactly what changes over this period. This information will provide product expiration dates, as well as guide potential changes in packaging, choices of product ingredients and additives, or even direct an evolution in the manufacturing process itself.
HOW DO WE TEST?
Real-time and accelerated stability testing are performed per ICH Harmonised Tripartite Guideline – Stability Testing of New Drug Substances and Products Q1A(R2). Real-time studies are run at 25°C/60% relative humidity (RH) and accelerated studies are run at 40°C/75% RH.