Define re-test period of API and Excipients
Stability – Definition: How the quality of an API or FPP varies with time under factors such as temperature, humidity and light.Studies also show how product-related factors influence stability: the properties of API/excipients, FPP composition, manufacturing process, and container-closure system. API: Active Pharmaceutical IngredientFPP: Finished Pharmaceutical Products Stability – purpose: a) To establish a re-test […]
