What Conditions are Tested in Stability Studies?

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Pharmaceutical companies know about the importance of testing with yearly serialisation testing. Stability studies are used to determine how a product will degrade over time. There are wide varieties of adjustments that can be made to these tests. One main example of a test is when the degradation rate of a product is looked at.

Tests can be administered to determine how a product degrades with use. In addition, other tests can be done to see how a product degrades while sitting on a shelf. Methods will differ varying on the needs of the product and company.

Understanding how a product degrades is vital for many reasons. Businesses need to determine if a product is worth continuing to research. If a product degrades earlier than expected, it could be time to make changes to the product.

The shelf life of a product is basically how long the product will remain effective. The shelf life of a product ends when a product is no longer usable. Products face tests, like the shelf life test, that they either pass or fail. Stability studies are a name given to these groups of tests.

There are many ways a product can fail a potential test. First, a company will determine if they want to run a single or multiple tests. In the event a single test is used, only one condition will be used. Conditions could mean anything from the appearance, taste, or texture of a product. These conditions are helped to understand how fit a product is for consumption.

A product can be tested for a subjective assessment which involves opinion. There are objective assessments which are based on actual measurements. Subjective assessments are better suited for tests where a wide range of opinions is needed. Objective studies will be more focused on concrete data measurements.

A shelf life needs to be quantified, if possible. A product, at some point, will begin to lose its effectiveness. Therefore, a product could end its shelf life duration when it has become 10 percent less effective. Analytical and research services help to ensure a product is tested in a wide variety of ways.

Unfortunately, statistics must count for some degree of accuracy. It’s tough to say a product is 100% error proof when a random occurrence could always happen. Track and trace pharmaceutical practices aimi to end mistakes with more accountability.

In closing, stability studies are a crucial part of any product. Tests can be administered on a product in a seemingly endless combination of ways. Many tests involve watching how a product degrades over time. Multiple environments are typically used to fully test the degradation rate of a product.

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