Authors : Suresh Kumar K.; Rajesh M.; Praveen N.

Volume/Issue : Volume 11 - 2026, Issue 9 - September

Google Scholar : https://tinyurl.com/5aaa9a7x

DOI : https://doi.org/10.38124/ijisrt/26sep786

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : Diabetes mellitus is one of the most prevalent chronic metabolic disorders worldwide, requiring long-term pharmacotherapy with a wide range of antidiabetic agents. The safety, efficacy, and quality of these drugs are highly dependent on the control of pharmaceutical impurities that may arise during synthesis, formulation, storage, or degradation processes. Impurities, including process-related impurities, degradation products, residual solvents, elemental contaminants, genotoxic impurities, nitrosamines, melamine, and cyanoguanidine, can adversely affect drug stability and patient safety even at trace levels. Therefore, impurity profiling has become a critical component of pharmaceutical quality assurance and regulatory compliance.

Keywords : Diabetes Mellitus, Antidiabetic Drugs, Impurity Profiling, Genotoxic Impurities, Nitrosamine Impurities, Melamine, Cyanoguanidine, Green Analytical Chemistry.

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