Forced Degradation Study an Essential Approach to Develop Stability Indicating Method
Manish Kumar Sharma* and Manoharan Murugesan
Department of Analytical Research and Development, Amneal Pharmaceuticals LLC, Brookhaven, New York, USA
- *Corresponding Author:
- Manish Kumar Sharma
Department of Analytical Research and
Development, Amneal Pharmaceuticals LLC
Brookhaven, New York, USA
E-mail: [email protected]
Received date: January 13, 2017; Accepted date: January 23, 2017; Published date: January 27, 2017
Citation: Sharma MK, Murugesan M (2017) Forced Degradation Study an Essential Approach to Develop Stability Indicating Method. J Chromatogr Sep Tech 8:349. doi: 10.4172/2157-7064.1000349
Copyright: © 2017 Sharma MK, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Forced degradation studies (stress testing) are very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities. For stable formulation development, understanding of chemical behavior, degradation pathways and degradation products of drug substance and drug product is very important. There is not much regulatory guidance available, which can provide step-by-step details on stress testing. Therefore, in present review paper we described the extensive overview of forced degradation studies (stress studies) by specifying strategy to perform stress studies and development of stability indicating method.