Stability Charts: Design and Application to Accelerated Stability Testing of Pharmaceuticals

The design of a nomographic chart to facilitate the analysis of stability data obtained in accelerated testing at elevated temperatures is described. The effects of errors on predictions made using the chart are discussed, particularly those arising from faulty assays, timing, and temperature control. An optimized stability testing program, based on the selection of elevated temperatures at equal intervals on a 1/T scale and on a predetermined assay schedule, is outlined for use with the chart.