Offering a comprehensive bulk drug stability program
Regis offers a comprehensive bulk drug stability program for Regis manufactured APIs in compliance with FDA and ICH guidelines. We provide stability testing to support your regulatory submissions, and ensure accurate evaluation of quality, strength, purity, potency and identity.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability studies test those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and efficacy. The testing includes as appropriate, the physical and chemical attributes.
Our Analytical Method Development department can assess or develop Stability-Indicating methods with force-degradation studies to support the shelf life of your API. Regis offers storage chambers which are fully validated and monitored 24/7 day with alert systems in place.
- Project Management
- Study design and support
- Development and validation of Stability Indicating Methods
- 24 hours a day, 7 days a week management of chambers with back-up units
- Retention, Logging and Tracking of samples
- Analytical testing of API
- Statistical interpretation of results in Real-time
- Time-point reports
- Comprehensive summary report
- Evaluation and Characterization of API's
Accelerated, Intermediate, and Long-Term Storage Conditions:
- 25°C / 60% R.H
- 30°C / 65% R.H
- 40°C / 75% R.H
- 5°C (refrigerated temp.)
- -20°C (freezer temp.)