Stability
Stability Testing for Regulatory-Ready Drug Products
At Q Laboratories, we specialize in comprehensive stability testing services for prescription drugs and pharmaceutical products. Our purpose-built facilities and expert team support your product development, regulatory submissions, and post-approval lifecycle management.
With over 25 stability chambers, including a walk-in real-time chamber, and all services conducted on a single campus, we offer unmatched efficiency, accuracy, and reliability for your stability studies.
Our Capabilities
Our scientists and stability specialists bring deep experience in pharmaceutical testing, ensuring precision and regulatory alignment throughout your study.
All studies are conducted in accordance with International Council for Harmonisation (ICH) guidelines, supporting global regulatory requirements.
We offer real-time, intermediate, and accelerated stability testing under ICH-recommended conditions.
Tailored testing environments to meet specific product or market needs, including refrigerated, frozen, and low/high humidity conditions.
Including freeze-thaw cycles, photostability, and stress testing to evaluate product robustness.
Scalable capacity for small to large-scale programs, including a full walk-in chamber for bulk studies.
Available ICH Stability Testing Conditions
| Study Type | Zone I & II (Temperate/Subtropical) | Zone III (Hot/Dry) | Zone IVa (Hot/Humid) | Zone IVb (Hot/Very Humid) |
|---|---|---|---|---|
| Long-Term (Real Time) | 25°C ± 2°C / 60% RH ± 5% | 30°C ± 2°C / 35% RH ± 5% | 30°C ± 2°C / 65% RH ± 5% | 30°C ± 2°C / 75% RH ± 5% |
| Intermediate | 30°C ± 2°C / 65% RH ± 5% | N/A | N/A | N/A |
| Accelerated | 40°C ± 2°C / 75% RH ± 5% | 40°C ± 2°C / 75% RH ± 5% | 40°C ± 2°C / 75% RH ± 5% | 40°C ± 2°C / 75% RH ± 5% |
Additional custom conditions available upon request (e.g., refrigeration at 5°C, freezing at –20°C, low humidity studies, high humidity studies, or freeze-thaw cycles).
One-Campus Advantage
All microbiology, chemistry, and stability services are performed on a single campus, ensuring:
- Faster turnaround times
- Reduced sample transfers and risk of error
- Direct access to scientists for technical support
- A seamless experience from protocol design through final reporting
