In forced degradation studies for API/drug product we are performing hydrolysis (acid, base & water), Oxidation, Photolysis and thermal degradation conditions. But why we are not performing reduction.
Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product. The
FDA and ICH guidances state the requirement of stability testing data
to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factor. Depends completely on the Climatic zone type.
Reduction processes often takes place under very harsh conditions , which are normally excluded during storage of medicines. Their modeling deserves attention for the development of analytical methods for control, including of purity of medicines.
The purpose of 'forced degradation' is to develop a stability indicating analytical method (SIAM) that is used for the setting specifications of the API and its related substances at QC release and expiry in a commercial product. It is 'very' unlikely that the drug product will encounter during its lifetime on the market, a reducing environment. More likely it will encounter Oxygen from air, thus oxidation is used.
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