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, cilt.238, sa.2, ss.90-99, 2015 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 238 Sayı: 2
  • Basım Tarihi: 2015
  • Doi Numarası: 10.1016/j.toxlet.2015.07.003
  • Dergi Adı: TOXICOLOGY LETTERS
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.90-99
  • Anahtar Kelimeler: 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 Üniversitesi Adresli: Evet

Özet

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.