Saturday, November 1, 2014

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 Ingredient
FPP: Finished Pharmaceutical Products

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