High-quality active pharmaceutical ingredients (APIs) are core to the manufacturing of safe and effective drugs. MRIGlobal’s Pharmaceutical Sciences portfolio encompasses a broad range of flexible capabilities in the API market. We have extensive experience in analytical method development, validation (preclinical through commercial), characterization/release testing and stability testing. With our stability testing for API synthesis we are able to observe the product in a variety of conditions and over varying lengths of time to monitor any change in the quality of the API.
Sometimes stability studies are a year long with time points every 3 months. Some studies are 5 years long with time points across those years. We look at the data and how it holds up over time in terms of data and purity.
Stability tests and storage for a range of materials
Our Program Management and communication form the backbone of what sets MRIGlobal apart from other contract research organizations. The team, which at a minimum consists of a dedicated project manager along with a technical lead, creates a plan for stability testing which is reviewed together with our client. The first step in stability testing is to either develop methods to test the specific drug the client brought us. If they come to us with methods already developed by another lab and they want us to develop the stability aspect, we can transfer those methods to ensure they provide the same results for us as they did for them.
Once methods are established and written procedures are established for the project, clients are able to send their material to our repository and stability facility for storage. Our capabilities allow us to handle a range of materials other labs can’t match. We’re able to work with cytotoxic and genotoxic materials in addition to light-sensitive compounds and moisture-sensitive compounds. Our repository can handle samples as small as a couple hundred milligrams with tests scaled appropriately to get the needed results.
Characterization work for new materials
If your material is entirely new and without reference standards, MRIGlobal is capable of performing a suite of analytical tests to characterize it and confirm its identity. We have a number of ways to determine what types of impurities exist and in what amounts as well as whether it has atmospheric water absorbed or residual solvents leftover from the manufacturing process.
Our stability and analytical chemistry group is unique because of our ability to do this type of characterization work entirely in-house.
Stability testing for API synthesis at MRIGlobal
As a not-for-profit contract research organization, MRIGlobal is an objective partner driven to solve our clients’ problems successfully. We specialize in defense, human health, pharmaceutical sciences, clinical diagnostics, energy and environment, agriculture, and global health.
To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.