CD Formulation: Accelerated Shelf-Life Testing to Assess Drug Stability

In recent decades, shelf-life prediction is increasingly recognized as an important and necessary part of any new product development. Fully aware of this, CD Formulation, a New York-based CRO company reputed for high-quality drug pre-formulation services, announced earlier this month to have launched long-term accelerated shelf-life testing for drug developers and pharmaceutical companies worldwide.

With the advance of controlled storage testing facilities, now accelerated shelf-life testing is seen as a real possibility by companies preparing for a product launch to determine the end of shelf life within time constraints. Researchers do not need to wait until the product reaches its end of life.

“Overall, accelerated shelf-life testing is an incredibly useful tool to help make commercial decisions before a drug product enters the market,” said the Marketing Chief of CD Formulation. “Such testing can not only help predict and set a shelf life for an ambient product, but can also access product stability in a short period, troubleshoot instability problems, and even assist formulation screening at initial stages of drug development.”

In most cases, intermediate accelerated aging studies at 30°C and 65% relative humidity (RH) are adopted, aiming to modestly increase the rate of chemical degradation or physical change of a substance or product intended for storage in a warm climate region.

In addition, CD Formulation also offers the following stability conditions for customers’ choices:

ï¬25°C ± 2°C / 60% relative humidity ± 5% relative humidityrnï¬30°C ± 2°C / 65% RH ± 5% RHrnï¬40°C ± 2°C/ 75% RH ± 5% RHrnï¬5°C ± 3°Crnï¬-20°C ± 5°C

“While conducting accelerated stability testing to evaluate pharmaceutical products, our technicians carefully monitor all environmental factors and will repeat the test until the product begins to fail. Expired drugs may be ineffective and may cause diseases. Therefore, after the testing project is completed, we’ll not only include a complete technical summary, of all test cases performed during the validation and their results, deviations, and resolutions in the report, but also offer storage recommendations specifying temperature, humidity and pH for clients if needed.”

Please visit https://www.formulationbio.com/long-term-accelerated-shelf-life-testing.html to explore more of CD Formulation’s accelerated shelf-life testing capabilities.