1. Levothyroxine synthesis impurities are neither mutagenic nor genotoxic: Insilico, Ames test and micronucleus test studies.
- Author
-
Rane R, Prabhune A, Kumar D, Kumar A, Sewlikar M, Suryawanshi M, Satpute B, Gawade B, and Sakat S
- Subjects
- Humans, Drug Contamination, Mutagens toxicity, Cell Line, Salmonella typhimurium drug effects, Salmonella typhimurium genetics, Micronucleus Tests methods, Thyroxine, Mutagenicity Tests methods
- Abstract
In vitro and in silico tests were used to assess the possible genotoxicity and mutagenicity of five impurities that may be present in levothyroxine, a drug used for thyroid hormone replacement therapy. Neither ToxTree nor VEGA (Virtual Models for evaluating the properties of chemicals within a global architecture) identified cause for concern for any of the impurities. Ames test results (doses up to 1 mg per plate), with or without metabolic activation, were negative. The micronucleus test with TK6 (human lymphoblastoid) cells, at doses up to 500 µg/mL, with or without metabolic activation, also gave negative results., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF