title: Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective.
abstract: Regulations alarmed the control of genotoxic impurities in drug substances at lower level based on the threshold of toxicological concern and daily dose. This review explores the details of various regulations and guidances, toxicology assessment, identification of structural alerts, synthetic origins, different synthetic approaches for elimination or control, various analytical determination strategies and pharmaceutical industry concern towards genotoxic impurities.
authors.affiliation: Hetero Drugs Ltd. (R&D), Plot No. B. 80 & 81, APIE, Balanagar, Hyderabad 500018, Andhra Pradesh, India. raman@heterodrugs.com
authors.forename: N V V S S
authors.initials: NV
authors.lastname: Raman
authors.forename: A V S S
authors.initials: AV
authors.lastname: Prasad
authors.forename: K
authors.initials: K
authors.lastname: Ratnakar Reddy
mesh_terms: D002623:Chemistry Techniques, Analytical; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004340:Drug Contamination; D004345:Drug Industry / Q000379:methods*; D005060:Europe; D009153:Mutagens / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009153:Mutagens; D004364:Pharmaceutical Preparations