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Accelerated stability data obtained at a single temperature is statistically evaluated, and the utility of such data for assessment of stability is discussed focussing on the chemical stability of solution-state dosage forms. The probability that the drug content of a product is observed to be within the lower specification limit in the accelerated test is interpreted graphically. This probability depends on experimental errors in the assay and temperature control, as well as the true degradation rate and activation energy. Therefore, the observation that the drug content meets the specification in the accelerated testing can provide only limited information on the shelf-life of the drug, without the knowledge of the activation energy and the accuracy and precision of the assay and temperature control.

chemical and pharmaceutical bulletin/chemical and pharmaceutical bulletin

Statistical evaluation of accelerated stability data obtained at a single temperature. I. Effect of experimental errors in evaluation of stability data obtained.