African Journal of Biotechnology Vol. 6 (18), pp. 2074-2077, 19 September 2007   

ISSN 1684–5315 © 2007 Academic Journals        

Full Length Research Paper

In vitro genotoxicity of piperacillin impurity-A

Magesh Vijayan^1*, M. Deecaraman¹ and Kalaichelvan Thangavelu Pudupalayam²

¹Department of Biotechnology, Dr. MGR Educational and Research Institute, N.H4, Periar E.V.R Road, Maduravoyal, Chennai.–600095, Tamil Nadu, India.

²University of Madras, CAS in Botany, Guindy Campus, Chennai – 600 025, Tamil Nadu, India.

*Corresponding author. E-mail: mahesharavind2006@yahoo.co.in. Tel: +91 9840343870.

Accepted 23 July, 2007

The manufacturing and storage of the piperacillin produce different impurities of various concentrations, which may influence the efficacy and safety of the drug. Since no report of genotoxicity data is available on the impurities of piperacillin, further studies were designed and conducted to provide information for establishing the safety profile and qualification of the piperacillin impurity-A. Salmonella typhimurium strains were exposed to Piperacillin impurity-A for Ames tests. Neither increase in number of revertants indicative of mutagenic activity nor inhibition of bacterial growth, indicative of cytotoxicity were observed up to 5 mg/plate both in the presence and absence of metabolic activation. Similarly, chromosomal aberration assay did not reveal any significant alterations up to 5 mg/culture as compared to the negative control both in the presence and absence of metabolic activation (S9 mix). The results of these studies indicate that Piperacillin impurity-A is non-mutagenic in Ames test and non-clastogenic in chromosomal aberration study.

Key words: Piperacillin impurity-A, Salmonella typhimurium, mutagenic activity, Chromosomal aberration