Stability Studies
Alpha carries out stability programs, including accelerated and on-going stability testing.
Stability testing of products, both legacy and new formulations, is important for a few reasons: To verify that the product is compatible with the package components. Although the formulation of the product may itself be stable and safe for the consumer to use, it may not be compatible with the proposed packaging. Some products cause the packaging components to corrode or decompose. Some packaging components may leach into the product causing mal-odors, discoloration or phase separation of the product.
To test the ability of the product to withstand changes in environment, reaction to heat and cold. To begin to determine the shelf life of the product.
At Microbiological Testing & Consulting, we have performed stability testing on products of all types. Depending on the test, this testing process can take from four weeks to three months. Our testing process involves consistent monitoring of the test samples, periodic selective testing, proper control and documentation and allows us to give you periodic progress reports.
Stability Testing Methods:
Pharmacopeial Methods like USP, EP, BP:
- Potency
- pH & Appearance
- HPLC & GC
- UV & IR
Any Validated Customer Methods
Storage Conditions:
- 25°C ± 2°C with 60% RH ± 5% RH
- 40°C ± 2°C with 75% RH ± 5% RH
Quality Systems
We use two CARON 6030 Chambers in our lab and the IQ, OQ and PQ on these chambers have been completed. The yearly calibration will be done by the same company which did the above qualification process. One chamber is set for accelerated study and the temperature is set at 40°C and humidity at 75% RH. The second chamber is set for long-term study and the temperature is set at 25°C and humidity at 60% RH.
Regulation Requirement
The world is divided into four climatic zones (I to IV). The FDA/ICH guidelines address the climatic zones I and II. Health Canada has endorsed the ICH guidelines in regards to stablity studies. We follow the ICH guidelines.