Advances in Bioengineering and Biomedical Science Research(ABBSR)
ISSN: 2640-4133 | DOI: 10.33140/ABBSR
Impact Factor: 1.7
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 1-[[(3-hydroxy-1- adamantyl) Amino] Acetyl] Pyralidine-(s)-2-Carboxamide (vildagliptin amide impurity) using Salmonella Typhimurium and Escherichia Coli Tester Strains
Author(s): T. Pavan Pradeep*, Ravi Kumar Nithyanandam and Debiprasad Padhy
The purpose of the Ames short-term bacterial reverse mutation experiment is to identify a variety of chemicals that can cause genetic harm that results in gene mutations. In this study, we investigated the mutagenic potential of 1-[[(3-hydroxy- 1-adamantyl) amino] acetyl] pyralidine-(S)-2-carboxamide (Vildagliptin amide impurity) using Salmonella typhimurium and Escherichia coli tester strains. The evaluation utilized plate incorporation methods to assess point mutations at the histidine locus in four strains of Salmonella and at the tryptophan locus in E. coli WP2uvrA, both with and without a metabolic activation system (S9). A series of concentrations (15.8 to 5000 μg/plate) were tested, revealing no significant decreases in revertant colony counts or cytotoxicity, as evidenced by the integrity of the bacterial lawn and lack of precipitation. Confirmatory assays at varying concen.. Read More»