Jornal de Cromatografia e Técnicas de Separação
Acesso livre

Abstrato

Forced Degradation Study an Essential Approach to Develop Stability Indicating Method

Manish Kumar Sharma and Manoharan Murugesan

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.