Forced Degradation and Stress Testing in Pharmaceutical Stability Analysis
Forced degradation and stress testing are critical components of pharmaceutical development and stability evaluation. These techniques deliberately subject active pharmaceutical ingredients (APIs) and drug products to extreme conditions to accelerate degradation, helping identify potential degradation products and validate stability-indicating analytical methods. Regulatory authorities including the FDA, EMA, and ICH emphasize the importance of these tests in ensuring drug safety, quality, and robust formulation design.
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