Forced decomposition/degradation Oxidation

To establish the degradation profile of a new drug, forced or stressed conditions such as hydrolysis, oxidation, photodegradation, and solid thermal decomposition are applied to the drug to generate degradation products that may be monitored by TLC or HPLC. 

The choice of stress conditions should be consistent with product decomposition under normal manufacturing, storage, and use conditions. Recommended stress factors include high and low pH, elevated temperature, photolysis, and oxidation. The extent of the stress applied in forced degradation studies should ensure formation of the desired amount (usually 10-20%) of degradation. 

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