Impurity Linked Genotoxicity assessment of the Antineoplastic Chemotherapy agent using Ames model

Abstract

Genotoxicity is the property of chemical agents that damage the genetic information in a cell causing mutations. Genotoxicity study based on in vitro and in vivo method, helps to identify the unwanted effect of chemical entity. Its helps to find the place of DNAdamaging and the recovery paths. In the field of pharmacy there are many regulatory authoritiesworking to control genotoxicic impurities and its affect. In the genotoxicity study there are so many tests like Ames test, Screen test and Potato disk test. The Ames test is a widely employed method that uses bacteria to assess the chemical mutations capacity in the DNA of the test organism. More formally, it is a biological OECD appeal assay to assess the mutagenic potential of chemical compounds. The Ames test performed during the study showed that it can be used to identify the mutagenicity of Cytosine. Which consider as a process impurity present in gemcitabine hydrochloride.