Our stability studies are designed to help pharmaceutical companies ensure the safety, efficacy, and quality of their products throughout their shelf life. With state-of-the-art stability chambers and a team of experts, we provide end-to-end solutions, from protocol preparation, storage, testing and the final stability summary report.
Our Stability Study Services Include
- Comprehensive Stability Testing: We offer stability testing under five different storage conditions to simulate real-world climate scenarios. Our conditions meet the requirements of ICH Q1A (R2), ensuring that your products undergo thorough, scientifically valid assessments.
- Testing Capabilities: Our team conducts a wide range of tests including physical, chemical, and microbial testing of stability samples. We ensure that your products meet the highest standards for quality and safety.
- Complete Study Process: From initial protocol preparation, sample loading, and pullout to analysis and reporting, we manage the entire stability study process. Our approach ensures accurate data and insightful conclusions.
- Reliable and Flexible Storage Conditions: Our walk-in stability chambers cater to different environmental conditions, including III and IVA climatic zones, with the following configurations:
- 25 ± 2°C / 60 ± 5% RH
- 30 ± 2°C / 65 ± 5% RH
- 30 ± 2°C / 75 ± 5% RH
- 40 ± 2°C / 75 ± 5% RH
- 5 ± 3°C
- Backup and Monitoring Systems: Our backup walk-in chamber is qualified for all four environmental conditions. All chambers are continuously monitored using 21 CFR Part 11 compliant software, ensuring that any excursions are detected promptly.
A remote alarm and SMS notification system provide immediate alerts in case of any deviations from the required conditions.
Frequently Asked Question ( FAQ’s )
We conduct stability studies for both drug substances and drug products, including physical, chemical, and microbial testing to ensure product integrity over time.
We offer five storage conditions as added above that simulate real-world climates, including temperature and humidity variations. Our stability chambers cater to ICH Q1A (R2) requirements.
The duration of a stability study can vary from six months to 5 years depending on the product and regulatory requirement. We provide customized study timelines based on your specific needs and regulatory guidelines. Contact us to discuss your project today!
The process starts with protocol preparation, followed by sample loading, testing under controlled conditions, and data analysis. Finally, we provide a comprehensive stability summary report.
Our stability chambers are continuously monitored using 21 CFR Part 11 compliant software. We also have a backup chamber and alarm systems in place to ensure consistent and reliable conditions throughout the study. By using qualified, routinely calibrated, and well-maintained instruments for testing of samples pulled from stability chambers as per defined frequency in protocol, we ensure the reliability of the stability study results
