Ensuring Product Efficacy and Safety Over Its Lifecycle

At MedPharm, we recognize that stability testing is crucial for demonstrating the shelf life, efficacy, and safety of pharmaceutical products. Our ICH-compliant stability programs ensure that your formulations maintain their physical, chemical, and microbiological integrity over time. This not only meets regulatory requirements but also supports successful product approvals.

Comprehensive Stability Testing Services

Our stability studies assess how temperature, humidity, light, and packaging conditions impact drug products, helping to:

✔ Determine product shelf life and expiration dating

✔ Optimize formulation stability during development

✔ Support regulatory submissions with robust data

✔ Ensure consistent quality throughout storage and distribution

1. Long-Term Stability Studies 

• Conducted under ICH Q1A(R2) guidelines
• Monitors product integrity over months to years
• Required for regulatory submissions and commercial approvals

2. Accelerated Stability Studies 

• Designed to predict long-term stability under elevated temperature and humidity conditions
• Rapidly assesses potential degradation pathways
• Helps optimize packaging and storage conditions

3. Stress Testing (Forced Degradation Studies) 

• Exposes products to extreme environmental conditions (heat, humidity, oxidation, photolysis)
• Identifies degradation pathways and establishes stability-indicating analytical methods
• Supports regulatory submissions by demonstrating formulation robustness

4. Photostability Testing 

• Evaluates the effect of light exposure on product stability
• Ensures drug formulations remain stable under real-world lighting conditions

5. Freeze-Thaw Stability Studies 

• Assesses product integrity after multiple freeze-thaw cycles
• Critical for biologics, emulsions, and temperature-sensitive formulations

Advanced Stability Storage Capabilities

MedPharm’s state-of-the-art stability chambers are fully qualified and monitored, offering:

 ICH-compliant storage conditions:  

• 25°C ± 2°C / 60% RH ± 5% RH (Long-term)
• 40°C ± 2°C / 75% RH ± 5% RH (Accelerated)
• 5°C ± 3°C, -20°C ± 5°C, -70°C ± 15°C (Cold storage)

Customized storage solutions for unique formulations   

Real-time monitoring and automated alerts for temperature excursions  

Ensure the Longevity and Success of Your Product

With a strong history in stability testing, MedPharm is your reliable partner for ensuring product quality from development to commercialization.