Accelerated and real–time shelf-life and stability studies to demonstrate that your products remain safe and effective during storage, transportation and under varying environmental and temperature conditions.
Light, humidity, temperature and time can wreak havoc on your product so its important to understand how your product performs under varying conditions to determine its shelf life. Our dedicated Stability team provides complete and tailored services at all stages for regulated products. This includes early and in-process Research & Development to Post-Approval Studies that are conducted in full compliance with Health Canada and FDA requirements, as well conforming to current ICH guidelines for new regulated substances and products.
Stability reports are tailored to your requirements and may include individual test point results, summaries at specified time periods or cumulative data at each study’s conclusion.
Shelf-life and stability studies support product quality and safety
We conduct a series of analysis over time to characterize microbiological, physical, and chemical changes that occur in a product with the goal of seeking answers to the following:
- Safety – Is the product safe for consumption?
- Functionality – Does the product perform the same in terms of physical properties (i.e., texture, appearance, growth of spoilage organisms such as yeast and mould, and pathogenic organisms) throughout the span of its shelf life?
- Quality and Marketability – Does the product maintain quality in supporting a positive consumer experience during time in terms appearance, flavour, texture?
Stability Testing Services
• Stability Protocol Design
• Shelf-Life Stability
• Accelerated and Intermediate Studies
• Stability testing for IND, NDA, ANDA
• Formulation Evaluation Stability Testing
• Forced Degradation Studies
• Freeze & Thaw Study
• Formulation Capability Study
Real-time (Direct) vs. Accelerated Shelf-Life Studies
Real time Studies
Real time studies are ideal for products that have a short shelf life. We conduct this study by storing the product under controlled conditions for longer than the expected shelf life. Throughout this period, the product is checked at regular intervals for visible changes.
Accelerated studies are conducted to shorten the trial length with the primary focus on chemical degradation, moisture loss, and colour changes. Studies are conducted by increasing storage temperature to speed up the rate of deterioration thereby allowing degradation impacts on the product to be seen sooner. However, accelerated studies are not ideal for all products especially if there is risk of microbial growth. These include foods with a biological component or water-based products for frozen shelf-life studies.