• MR. DINESH B. YADAV
• MR. RANA HARSHRAJ
• DR. MITTAL MAHESHWARI
• DR. PRAGNESH PATANI

Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses about the current trends in performance of forced degradation studies by providing strategy for the conduct of studies, degradation mechanisms and also describes the analytical methods helpful for development of stability indicating method. Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies. Statins, a class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review

Degradation conditions, Degradation product, forced degradation, Stability indicating method, Stress testing.

"DEVELOPMENT FOR FORCED DEGRADATION AND STABILITY STUDIES OF API FORMULATION: A REVIEW", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.7, Issue 2, page no.807-815, February-2020, Available :http://www.jetir.org/papers/JETIR2002113.pdf

"DEVELOPMENT FOR FORCED DEGRADATION AND STABILITY STUDIES OF API FORMULATION: A REVIEW", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.7, Issue 2, page no. pp807-815, February-2020, Available at : http://www.jetir.org/papers/JETIR2002113.pdf