Ведомости Научного центра экспертизы средств медицинского применения (Feb 2018)

Column chromatography USED in purification of genotoxic impurity sample of imatinib mesylate substance

  • V. I. Krylov,
  • S. V. Moiseev,
  • O. V. Knyazkina,
  • V. A. Yashkir,
  • V. A. Merkulov

Journal volume & issue
Vol. 0, no. 3
pp. 42 – 45

Abstract

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The article describes a simple method for purifying N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine for further use as a standard for quantitative determination of genotoxic impurities substance imatinib mesylate. Experimentally proved choice of sorbent used for purification of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine. The advantage of column chromatography on neutral alumina prior to crystallization methods presented in the literature. Comparative chromatographic and spectral characteristics of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine before and after purification. NMR spectroscopy evaluated quantitative content of the target substance in the purified sample.

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