Conduct Humid and High-Temperature Forced Degradation Studies for Risk Profiling
Understanding the Tip: Why forced degradation under stress conditions is essential: Forced degradation studies are a cornerstone of stability science, designed to expose the drug product and API to extreme conditions to accelerate chemical breakdown. Among the most informative conditions are high temperature (e.g., 60°C) and elevated humidity (e.g., 75% RH), which mimic worst-case scenarios…
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