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Tag: stability regression trend plots

Identifying Degradation Trends in Intermediate Stability Studies

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Identifying Degradation Trends in Intermediate Stability Studies How to Identify and Interpret Degradation Trends in Intermediate Stability Studies Intermediate stability studies—typically conducted at 30°C ± 2°C / 65% RH ± 5%—are a critical component of pharmaceutical development and lifecycle management. While these studies provide a moderate stress condition between long-term and accelerated stability testing, their…

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  • Include In-Use Stability Studies for Reconstituted and Multidose Formulations

    Understanding the Tip: Why in-use studies are essential: In-use stability studies evaluate how a pharmaceutical product performs after it has been opened, reconstituted, or prepared… Read more

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