Phase 5: Stability Studies

Phase 5: Stability Studies contains 4 topic pages in Pharmaceutics.

Stability studies evaluate how the quality of a drug substance or drug product changes over time under the influence of environmental factors — principally temperature, humidity, and light — with the purpose of establishing an appropriate shelf-life, or expiry period, and the storage conditions under which that shelf-life can be guaranteed. This area of pharmaceutics is governed comprehensively by the ICH Q1 series of guidelines: Q1A(R2) for the general testing of new drug substances and products, Q1B for photostability, Q1C for stability testing requirements applicable to new dosage forms, and Q1E for the statistical evaluation of stability data. This chapter addresses the testing conditions specified under this framework, the manner in which protocols are tailored to different dosage form categories, the kinetic models used to characterise degradation, and the methods used to translate degradation data into a defensible shelf-life.