Determination of the impurities in drug products containing montelukast and in silico/in vitro genotoxicological assessments of sulfoxide impurity

Emerce E., Çok İ., Degim I. T.

TOXICOLOGY LETTERS, vol.238, no.2, pp.90-99, 2015 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 238 Issue: 2
  • Publication Date: 2015
  • Doi Number: 10.1016/j.toxlet.2015.07.003
  • Journal Name: TOXICOLOGY LETTERS
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.90-99
  • Keywords: Genotoxic impurities, (Q)SAR analysis, Ames test, Chromosomal aberration test, Hplc, Regulations, MICROTITRE FLUCTUATION TEST, IN-SILICO, GENOTOXICITY EVALUATION, PHARMACEUTICAL QUALITY, MUTAGENICITY, ASSAY, IDENTIFICATION, LEVOFLOXACIN, SENSITIVITY, VALIDATION
  • Gazi University Affiliated: Yes

Abstract

Impurities affecting safety, efficacy, and quality of pharmaceuticals are of increasing concern for regulatory agencies and pharmaceutical industries, since genotoxic impurities are understood to play important role in carcinogenesis. The study aimed to analyse impurities of montelukast chronically used in asthma theraphy and perform genotoxicological assessment considering regulatory approaches.