Stability-Indicating Methods and Stability Studies

Stability-Indicating Methods and Stability Studies contains 3 topic pages in Pharmaceutical Quality Assurance.

Stability testing provides the scientific evidence that a drug substance or drug product retains its identity, strength, quality, and purity throughout its intended shelf life when stored under defined environmental conditions. This chapter examines the scientific principles governing chemical and physical degradation of pharmaceuticals, the design of stability-indicating analytical methods capable of resolving the intact drug from its degradation products, and the regulatory framework, principally the International Council for Harmonisation Q1 series of guidelines, that governs stability study design, storage conditions, and data interpretation.