Stability testing
Supporting your stability programs
Comprehensive Stability Testing Services
Pharmaceutical stability testing involves gathering information about products by subjecting them to defined time periods and particular environmental conditions.
Stability testing provides essential data on how factors such as temperature, humidity, and light exposure can affect drug products.
Profarma offers GMP-certified ICH stability and ongoing stability studies for both small and large molecules, serving global pharmaceutical clients, including innovators and generic manufacturers. We analyze a diverse range of finished products such as tablets, capsules, ampoules, topical products, injectables, and powders.
Stability Testing Services
Profarma’s stability testing services include:
- Long-term stability studies
- Accelerated stability studies
- Intermediate stability studies
- Stress testing
- Photostability testing
- Customized stability studies
Frequently Asked Questions
What are the different types of stability testing?
Profarma offers various types of stability testing to ensure your product’s shelf life and quality:
Real-Time Stability Testing: We store samples under recommended conditions and test them at predetermined intervals to determine shelf life.
Accelerated Stability Testing: We subject samples to elevated stress conditions to quickly identify potential stability issues.
Forced Degradation Studies: We expose samples to extreme conditions (e.g., high temperature, light, pH) to identify degradation products and establish the method’s robustness.
Long-Term Stability Testing: We monitor samples over an extended period to confirm long-term stability under typical storage conditions.
On-Going Stability Testing: Continuous monitoring of commercial product batches to ensure consistent quality over time.
Profarma’s comprehensive stability testing services ensure your products maintain their safety, efficacy, and quality throughout their shelf life.
What conditions are typically used in stability testing?
Stability testing typically involves storing samples under a variety of conditions, including:
- Standard Conditions: Usually at 25°C/60% RH (relative humidity).
- Accelerated Conditions: Elevated temperatures and humidity, such as 40°C/75% RH.
- Stress Conditions: Extreme conditions like high temperature, high humidity, light exposure, and varying pH levels.
These conditions help identify how products degrade over time and under different environmental factors.
How does Profarma ensure accurate stability testing results?
Profarma uses state-of-the-art facilities and equipment to conduct stability testing. Our experienced team follows rigorous protocols and regulatory guidelines to ensure accurate and reliable results. We also provide detailed documentation and reporting for regulatory submissions.
What types of products can Profarma test for stability?
Profarma can conduct stability testing for a wide range of pharmaceutical products, including:
- Tablets and capsules
- Injectables and IV solutions
- Topical creams and ointments
- Inhalation products
- Biologics and biosimilars
Our comprehensive services cater to diverse product types and formulations.