IN-VITRO GENOTOXIC EVALUATION OF THE SULFASLAZINE IMPURITY - (2-HYDROXY-5-[N-(4-{[4 -PYRIDIN- 2 -YLSULFAMOYL) PHENYL] SULFAMOYL}PHENYL)DIAZEN-1-YL]) BENZOIC ACID BY CHO CHROMOSOMAL ABERRATION TEST
Author(s):
Surya N Suryadevara, A. Shanthi Priya, K. Hema Kumar, Dr. A. Krishna Sathya
Keywords:
Chromosome aberration, Impurity, Mutagen, Mammalian cells.
Abstract
(2-hydroxy-5-[N-(4-{[4 -pyridin- 2 -ylsulfamoyl) phenyl] sulfamoyl}phenyl)diazen-1-yl]) benzoic acid is identified as impurity in Sulfasalazine drug. This impurity considered as in-house impurity since regulatory agencies not reported completely. It is mandatory to test toxicology effects of this impurity for regulatory compliance. The chromosome aberration test is one of the sensitive methods to identify or evaluate the mutagenicity of environmental mutagens and/or carcinogens using cultured mammalian cells. This study the clastogenic activity was tested by chromosomal aberration test by using CHO cell lines. Several chromosomal abnormalities were tested in this experiment. This experiment result was insignificant pertaining to Chromosomal aberrations. Chromosomes of Cell lines does not show any abnormality in any given concentration of the impurity.
Article Details
Unique Paper ID: 157542

Publication Volume & Issue: Volume 9, Issue 7

Page(s): 449 - 456
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