Q: What is the bracketing approach in stability testing? A: The bracketing approach involves testing only samples at the extremes of specific factors, such as strength, container size, or fill volume. The assumption is that intermediate samples behave similarly to these extremes. Q: When is bracketing most effective? A: It works best when there is…
Accelerated stability testing simulates extreme conditions to predict product shelf life. But if it fails, then refer below points: Focus on Long-Term Data: Root Cause Analysis: Regulatory Compliance: Intermediate Data: Read also:
A list of common interview questions and answers on stability testing of pharmaceutical products are given below: Q. What is stability in pharmaceuticals? Stability in pharmaceuticals refers to the ability of a drug product to maintain its physical, chemical, and microbiological properties within a specified range over a given period of time under the influence…