Stability Testing and Services
Evaluation of stability is a critical aspect of drug substance and drug product testing. Whether you have predetermined stability protocols or require IAL to develop the protocol, IAL will be an important member of your team. We will work with your organization to develop a stability program that will work for you. Expertise in analysis along with state-of-the-art instrumentation enables us to devise studies that will not only meet labeling and regulatory requirements but will also be cost effective and timely.
Our in-house storage is comprised of environmental stability chambers that operate independently and have individual temperature and humidity controls. All chambers are continuously monitored by a Rees Back-Up System (hardwired security system) and utilize back-up generators to prevent loss of power. If an excursion occurs, an alarm system contacts critical personnel immediately. The system will continue to contact critical personnel until the situation is addressed and rectified. All alarm systems function 24 hours a day 7 days a week.
IAL also accepts stability samples that have been stored at your facility and require testing only. We will also store samples in our chambers and ship them to your facility if necessary.
Stability indicating methods are either developed and validated in house or supplied by our clients. All client supplied methods are transferred according to appropriate protocols. IAL's professional staff will work closely with your organization if methods need to be developed and validated. We will ensure all methods that are developed will be stability indicating and we will ensure that all methods provide the critical data that is required to correctly assess your product over time and environmental conditions.
Customized reports are available for all our clients. It is important to us to make sure that your needs are met analytically but we also want to work with you to ensure that we effectively optimize your operation and efficiency. Typically, IAL will issue a tabular report that is cumulative at each time interval. We can also present our data in a format that will be directly downloaded into your database. Trending will be simplified and ease of operation achieved. Any out-of-specification results will be immediately reported and we will work together to perform the investigation and resolve any issues.
Stability Chamber Conditions: ICH Guidelines:
- Accelerated Conditions (40°C / 75%RH)
- Intermediate Conditions (30°C / 60%RH)
- Long-Term Conditions (25°C / 60%RH)
Stability Services and Sample Testing:
- Protocol Writing
- Stability Indicating Method Development
- Stability Indicating Method Validation
- Method Transfer
- Stability Storage
- Stability Testing for a Drug Substance and Impurities
- Stability Testing for a Drug Product and Impurities
- Stability Testing Cosmetics and Nutraceuticals
- Comparator Product Stability and Testing
- Formulation Evaluation Stability Testing
- Forced Degradation Studies
- Freeze Thaw Studies
Contact us to obtain excellence in service and quality data, and to allow us to become a valuable and trusted member of your team.