Stability Testing
Stability testing of pharmaceutical products and storage follow a complex set of procedures involving considerable time, cost and scientific expertise in order to build in quality, efficacy and safety in drug formulations. Stability testing or GMP stability testing is critical at every step during drug or product development to determine the shelf life and storage conditions in conformance with stipulated standards.
Stability testing or studies is some of the most important step during the drug development process because it is required to assure the identity, potency and purity of ingredients, as well as those of the formulated pharmaceutical products or Active Pharmaceutical Ingredients (API). Evaluation of these formulations or products against varying environmental conditions such light, temperature, moisture, etc. provide relevant, real-time insights about their applications and how they may differ due to changes in storage factors.
For a pharmaceutical or chemical company, choosing an experienced stability partner who possesses the right infrastructure – such as stability walk-in chambers, photostability chamber, etc. – and the analytical resources for stability testing can determine the product success or failure.
Storage
Precise Analytics Lab. is well equipped with stability walk-in chambers that can be set at different temperatures and humidity with validated monitoring systems. We also have a photo stability chamber to carry out photo stability testing. Our technologically-enhanced stability testing labs and experienced analysts and scientists provide GMP stability testing for pharmaceutical companies.
We carry out all ICH and Specific Conditions stability studies and the stability studies are carried out under the following range of stability conditions.
| Temperature | Humidity |
|---|
| 30°C ± 2°C | 65% ± 5% |
| 30°C ± 2°C | 75% ± 5% |
| 40°C ± 2°C | 75% ± 5% |
| 25°C ± 2°C | 60% ± 5% |
| 2°C - 8°C | No Humidity |
The features offered by our stability testing labs include:
- Long-term, real-time stability studies/testing
- Short-term accelerated stability studies
- Photo stability and forced degradation studies
Testing
Our stability testing processes serve to enhance product and drug development by critical identification of stability that is essential for product validation. Stability testing involves determining degradation factors and time taken for degradation. Routine assays for various parameters such as temperature, moisture content, residue presence, microbial presence, etc. are also conducted.
During the period of stability testing, we periodically test for identification, physical appearance, disintegration, dissolution, loss on drying, related substances, assay, residual solvents, microbial testing etc., to determine the accurate stability of product. Our experienced team and high-technology infrastructure complement each other to provide stability studies that are reliable in real-time conditions thought the product lifecycle.
Forced degradation studies during stability testing include the following parameters:
- Acid and Alkaline Hydrolysis
- Oxidation
- Thermal
- Humidity
- Fotolic
- Fluorescent light
- Metallic Ions (Cu II or Fe III)
Contact us for your stability testing or photo stability testing needs.
