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Pharma Stability: Insights, Guidelines, and Expertise

Tag: stress testing for cold exposure

Impact of Freeze-Thaw Cycles on Accelerated Stability Studies

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Impact of Freeze-Thaw Cycles on Accelerated Stability Studies Evaluating the Impact of Freeze-Thaw Cycles in Accelerated Stability Studies While accelerated stability studies typically focus on high-temperature and humidity stresses, real-world storage and transportation conditions often expose pharmaceutical products to freezing and thawing. These freeze-thaw cycles can compromise drug integrity, especially for biologics, emulsions, and sensitive…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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