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Forced Degradation

Meaning

Forced Degradation, also known as stress testing, is a critical pharmaceutical practice involving the intentional exposure of a drug substance or drug product to extreme environmental conditions to accelerate its breakdown and generate degradation products. These conditions typically include high heat, humidity, intense light, and exposure to acid, base, or oxidative agents. The primary purpose is to elucidate the intrinsic stability of the molecule and to validate the analytical methods used to separate and quantify the drug from its degradation impurities. This information is vital for formulating stable hormonal products and determining appropriate storage conditions.