• Indexing List

International Journal of Pharmaceutical Chemistry and Analysis


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


Full Text PDF Share on Facebook Share on Twitter


Author Details: Gunjan Rao, Anju Goyal

Volume : 3

Issue : 3

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 110

Article End Page : 116


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