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International Journal of Pharmaceutical Chemistry and Analysis


Development of stability indicating studies for pharmaceutical products: an innovative step


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Author Details : Gunjan Rao, Anju Goyal

Volume : 3, Issue : 3, Year : 2016

Article Page : 110-116


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Abstract

A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety, quality and efficacy throughout the shelf life. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. Stability testing provides evidence that the quality of a drug substance or drug product under the influence of various environmental factors changes with time. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review. This review article includes introduction about stability studies types of stability studies and chemical reactions takes place during degradation etc. This article also includes the forced degradation studies and shelf life estimation of pharmaceutical products.

Keywords: Stability, Pharmaceutical, Environmental, Chemical reaction, Forced degradation, Shelf life

 

How to cite : Rao G, Goyal A, Development of stability indicating studies for pharmaceutical products: an innovative step. Int J Pharm Chem Anal 2016;3(3):110-116

Copyright © 2016 by author(s) and Int J Pharm Chem Anal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC-BY-NC 4.0) (creativecommons.org)