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1 Apr 2019

What is a Stability-indicating assay method?

A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in the chemical, physical or microbiological properties of the drug substance and drug products are specific so that the content of active ingredients and degradation products can be accurately measured without interference”.

Generally forced degradation/stress testing is used to generate the samples for stability-indicating assay methods. Forced degradation/stress testing is defined as “the stability testing of drug substance and drug product under conditions exceeding those used for accelerated stability testing”.

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