Stability testing is the statistical analysis of how long a pharmaceutical product can be stored without any change in its original chemical composition.
Pharmaceutical products when stored for long durations tend to undergo changes and release byproducts. Stability testing provides evidence on how certain pharmaceutical drugs can be stored at room temperature and in controlled condition.
The physical, chemical and microbial properties of a pharmaceutical product may change under extreme storage conditions. That’s why; the shelf-life of a product has been studied during the stability testing.
The pharmaceutical industry conducts this testing to develop a new product and establish the shelf-life of a product.
Here’s why stability study is important for the pharmaceutical industry.
- Shelf-Life Determination
- Storage Condition Recommendation
- Elimination of Impurities
- Product Development
- Ensures Quality
- Packaging Material Selection
- Legal Approvals
The 4 widely practiced forms of stability testing are:
- Real-Time Stability Testing.
- Retained Sample Stability Studies.
- Cyclic Temperature Stress Testing and
- Accelerated Stability Testing.