Projection Op Tentative Expiry Date Prom One-Point Accelerated Stability Testing

Abstract

The Food and Drug Administration (FDA) is proposing that a satisfactory three-month stability testing of a drug product at 37 to 40 °C and 75% or higher relative humidity can be employed to project a tentative expiry date of two years from the date of manufacture. This proposal is theoretically analyzed and its limitation is established. A successful projection of the expiry date according to FDA's proposal depends on the drug level at the end of the accelerated stability testing, the activation energy, and the temperature of the accelerated condition and the normal storage condition. The applicability of this method in assessing the stability characteristics of pharmaceutical formulations in the development process is discussed.