Glossary
Stability
What is Stability?
Stability in the pharmaceutical industry refers to the capacity of a pharmaceutical product to remain within specified physical, chemical and microbiological specifications over time under recommended storage conditions. This ensures that the product retains its quality, efficacy, and safety throughout its shelf life.
What is the use of stability in pharma?
- Stability studies are conducted to assess the quality and shelf life of pharmaceutical products, ensuring that they meet regulatory requirements and remain safe and effective for patient use.
- Stability testing involves subjecting the product to various storage conditions (e.g., temperature, humidity, and light) to evaluate its stability under simulated environmental factors.
- The data obtained from stability studies is used to establish product expiration dating and storage conditions, as well as to support the development of suitable packaging and labelling.
What are the different types of stability testing methods used in pharma?
In the pharmaceutical industry, various types of stability testing methods are used to assess the quality, safety, and efficacy of drug substances and products over time. These methods are crucial for ensuring compliance with regulatory requirements and maintaining the integrity of pharmaceutical products throughout their shelf life. The different types of stability testing methods used in pharma include:
- Accelerated stability testing: Exposing drug products to elevated temperature and humidity conditions to predict long-term stability
- Real-time stability testing: Storing drug products under recommended storage conditions and testing at regular intervals over the proposed shelf-life
- Stress testing: Exposing drug products to extreme conditions like heat, humidity, oxidation, photolysis and hydrolysis to identify potential degradation pathways
