An Exploratory Study on Genotoxic Impurities in Tandospirone Citrate

SUN Baihao, GUAN Haoyue, NIU Jianzhao

Chinese Pharmaceutical Journal ›› 2023, Vol. 58 ›› Issue (20) : 1869-1875.

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Chinese Pharmaceutical Journal ›› 2023, Vol. 58 ›› Issue (20) : 1869-1875. DOI: 10.11669/cpj.2023.20.009

An Exploratory Study on Genotoxic Impurities in Tandospirone Citrate

  • SUN Baihao, GUAN Haoyue*, NIU Jianzhao*
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Abstract

To explore the possible genotoxic impurities in tandospirone citrate to ensure the safety of medication. METHODS Based on the synthesis process of tandospirone citrate, combined with the warning structure of genotoxic impurities, computer toxicology prediction and Ames test, the classification of genotoxicity of impurities was determined. RESULTS 1,4-dibromobutane was mutagenic, which was a class 2 genotoxic impurities in tandospirone citrate. CONCLUSION 1,4-dibromobutane is a class 2 genotoxic impurity of tandospirone citrate, and its residue should be strictly controlled in the drug to ensure the safety of medication.

Key words

tandospirone citrate / computational toxicology assessment / Ames test / genotoxic impurity

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SUN Baihao, GUAN Haoyue, NIU Jianzhao. An Exploratory Study on Genotoxic Impurities in Tandospirone Citrate[J]. Chinese Pharmaceutical Journal, 2023, 58(20): 1869-1875 https://doi.org/10.11669/cpj.2023.20.009

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