A critical evaluation of the determination of shelf-life using a statistical approach

Abstract

The study gives an evaluation of shelf-life determination of pharmaceutical drug products and simulation studies which illustrate the stability of pharmaceutical products under the harsh storage conditions that may be encountered during the transportation process. The drug chosen for the studies performed was ramipril, an angiontensin converting enzyme (ACE) inhibitor which can degrade via two main pH-dependent pathways depending on the formulation of the dosage form. The study has been performed on a formulation, which owing to its basic nature, results in preferential degradation of ramipril to the diacid (impurity E) rather than the diketopiperazine (impurity D) impurity.