GENOTOXIC IMPURITIES - AN OVERVIEW

  • *Usha Yadav1, Priyanka Dhiman1, Neelam Malik1, Anurag Khatkar1, Neelam Redhu2, D.P. Singh3 1Faculty of Pharmaceutical Sciences, M.D.University, Rohtak, India 2Department of Microbiology, Punjab Agriculture University, Ludhiana, India 3Bhagwant Institute of Pharmacy, Muzaffarnagar, Bijnor, India

Abstract

Genotoxic impurities (GTIs) in pharmaceuticals are of increasing concerns to both pharmaceutical industries and regulatory agencies due to their carcinogenic potency for humans. Practical guidance with respect to the analytical determination of diverse classes of GTIs is currently lacking in the literature. This article provides an industrial perspective with regard to the analysis of GTIs that are commonly encountered during drug development. Determination of these impurities at ppm levels requires highly sensitive analytical methodologies, such as LC/MS, LC-MS/MS, and RP-LC. The present review emphasized on the various methods used for the detection and quantification of genotoxic impurities.

 

Keywords: Genotoxicity, Mutations, Teratogenicity, Cancer Chemotherapy

 

Published
2013-10-30
How to Cite
Neelam Redhu2, D.P. Singh3 *Usha Y. P. D. N. M. A. K. (2013). GENOTOXIC IMPURITIES - AN OVERVIEW. Journal of Biomedical and Pharmaceutical Research, 2(5). Retrieved from http://www.jbpr.in/index.php/jbpr/article/view/356
Issue
Vol. 2 No. 5 (2013)
Section
Review Articles

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