Authors : Pooja K. Deshpande; Dinesh D. Dantkale; Mahesh T. Mali; Santosh N. Rawool; Sharad D. Rode

Volume/Issue : Volume 11 - 2026, Issue 6 - June

Google Scholar : https://tinyurl.com/mwcj55wh

Scribd : https://tinyurl.com/bdhnrcwa

DOI : https://doi.org/10.38124/ijisrt/26jun640

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Abstract : The control of impurities in drug substance and drug formulation is critical concern in the pharmaceutical industry. The impurities are potent and cause serious toxic effects which are harmful to human health. The control of such impurities is mandatory for pharmaceuticals companies to get the regulatory approval of their pharmaceutical products. Hence the International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines provide guidance to the industry for manufacturing high quality medicines. Canagliflozin is Sodium-Glucose CoTransporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes. Canagliflozin is commercially available since 2013 in United states, Europe and it is included in the world health organization’s essential medicines list. Canagliflozin is chemically D-glucitol compound comprising sugar moiety. This review aims to provide comprehensive overview of canagliflozin impurities and different analytical methods for detection.

Keywords : Impurities, International Conference on Harmonization (ICH), Canagliflozin, SGLT Inhibitor.

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