What is Stability Testing ?
Stability Testing in Pharma
Stability studies are one of the essential and crucial aspects of pharmaceutical development. It is a very important aspect of the drug product or drug substance manufacturers. Stability testing or studies are done to examine the influence of external factors like light, temperature, and humidity on the product characteristics.
Goals of Stability Studies:
- To determine the shelf life
- To identify the degradation products
- To access the product quality over time.
- To determine the ideal storage conditions
- To identify potential degradation pathways.
Classification of Stability Studies:
- Physical Stability Studies
- Chemical stability Studies
- Microbial Stability Studies
Physical Stability:
It refers to the stability of the physical characteristics of the drug, such as appearance, texture, color, odor, dissolution, and particulate matter etc.
- Testing includes testing for changes in appearance, moisture content, crystallization, or other physical parameters of the drug.
Chemical Stability:
During chemical stability studies the drugs chemical composition is assessed under various environmental conditions over a period of time and also the chemical stability of the excipients. It involves assays to detect degradation products, potency testing, pH measurement, and chemical identification tests.
Microbiological Stability:
These studies access the product’s ability to resist microbial contamination and maintain sterility within acceptable limits over period of time. and these studies includes tests like test for sterility, preservative efficacy, and microbial limit tests.