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THE PHARMA REVIEW (MAY JUNE 2016)

Prologue to Forced Degradation and Stability Study of Drug Substance and Product

Pratik M Tailor

Introduction: Forced degradation and Stress testing is essential for various aspect of manufacturing as well as storage part. This study includes exposure of the various factors and degradation behavior of drug substance. Stress testing should be done according to the climatic zone and condition for accelerated, intermediate or for long term. Many of the regulatory application require the data of major degradation product and stability. Stability indicating method should be developed to estimate drug in presence of the degraded products. This article addresses the beginner level information for degradation and stress testing. 

 

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