Article 4


Regulatory guidance on Forced degradation studies- A review

Author (s): Tulasi Pradhan, Susanta Kumar Panda

Royal College of Pharmacy and Health Sciences, Berhampur- 2, Odisha


Forced degradation studies are an integral part of drug development process. This is a method which promotes the intrinsic degradation rate of a product or material with applying extra stress conditions. It illustrates the chemical characteristics of the compound that aids in the creation of pharmaceutical formulation and packaging. The current study examines numerous regulatory considerations, forced degradation methods, and degradation characteristics for diverse pharmaceuticals. The drug substance and drug products are treated to extremely ambient condition throughout the forced degradation procedure to assess their stability. The stability in forced degrading circumstances should be determined in order to the applicability of stability methodologies. It is often used to establish storage conditions and enhance the formulation work flow.

Keywords: Forced degradation, stability, strategy, method development, ICH guidelines, FDA and characterization.

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