STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENT [API]

Stability plays an important role in drug development process. It explains several factors that affect the quality of a drug substance or drug products varies with time under the influence of environmental factors such as temperature, humidity and light. Stability studies play a vital role to decide the re-test period and shelf life for the drug substance and recommended storage conditions of API. ICH and EMEA guidelines define stability data package for new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan and United States.