The Importance of Stability Testing
The pharmaceutical science team at MRIGlobal is here to make sure you get the stability data you need when submitting a drug for approval with the FDA. With regular internal and external auditing and extensive GMP experience, you can trust the quality of our labs and scientists. But why is stability testing important?
Let’s explore.
Why is stability testing important?
Stability testing in pharmaceutical analysis is important to establish the safety and efficacy of the drug. Through stability testing, we provide evidence on how the quality of a drug changes with time under a variety of environmental influences. We can test for stability under different temperatures, humidity levels, and light levels as recommended by ICH (International Conference on Harmonization), or at custom conditions.
With stability testing we determine the optimum conditions under which to store drugs for maintaining efficacy and shelf life. For example, consider the variety of COVID-19 vaccines that have been cleared by the FDA and administered since early 2021.
Differences in storing vaccines
The single dose Johnson and Johnson vaccine is stable for up to 2 hours at room temperature or 6 hours when refrigerated between 2C and 8C. Thawed, undiluted Pfizer vaccine doses were authorized to be stored between 2C and 8C for up to 5 days initially. Recently, the FDA authorized the vials to be stored at those temperatures for up to a month. Without stability testing and continued analysis, doses of the vaccine could have been thrown out when they were still perfectly good to use.
Getting started with MRIGlobal
Contact MRIGlobal and get started with trusted stability testing and more pharmaceutical sciences services.
As a not-for-profit contract research organization, we have proven ourselves as an objective partner driven to make our clients’ products more successful. We specialize in defense, human health, pharmaceutical sciences, in-vitro 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.
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