Define stability study and its necessity? : Pharmaceutical Guidelines

Define stability study and its necessity?

Interview Question #041 - Define stability study and its necessity?
Stability study is defined as “stability testing is to provide evidence how quality of product varies with time under influence of temperature, humidity & light”.
Stability study is essential because it helps to:
  • Establish a re-test period for drug substance 
  • Establish a shelf life for drug product 
  • Recommend storage conditions for products



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