T. Pavan Pradeep
Clinical Pharmacology and Pharmacokinetic Department, MSN Labs Pvt. Ltd, India
Publications
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Research Article
Bacterial Reverse Mutation Test of 2-(3-hydroxyadamantan-1-yl)-1-imino-hexahydro-pyrrolo [1,2-a] pyrazin-4-one (Vildagliptin cyclic amidine impurity) using Salmonella Typhimurium and Escherichia Coli
Author(s): T. Pavan Pradeep*, Ravi Kumar Nithyanandam and Debiprasad Padhy
The Ames Salmonella/microsome mutagenicity assay (Salmonella test; Ames test) is a short-term bacterial reverse mutation assay specifically designed to detect a wide range of chemical substances that can produce genetic damage that leads to gene mutations. In this study, we are going to investigate the mutagenic potential of 2-(3-hydroxy-adamantan- 1-yl)-1-iminohexahydro-pyrrolo[1,2-a] pyrazin-4-one (Vildagliptin cyclic amidine impurity) using Salmonella typhimurium and Escherichia coli tester strains. The evaluation was conducted to assess point mutations at the histidine locus in four strains of Salmonella typhimurium and the tryptophan locus in E. coli WP2uvrA. The experiment employed the plate incorporation method, both with and without a metabolic activation system (S9). Cytotoxicity was assessed by measuring the thinning of the bacterial lawn and the reduction in revertant colon.. Read More»
