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<p>A high-performance liquid chromatography (HPLC) method for determining related impurities in the substance of ALM-802S, a new compound with antiarrhythmic activity, has been developed and validated. The developed method allows the detection of both process impurities and impurities of ALM-802S oxidation products with contents of less than 0.05% and the collection of data on the stability of the substance during its production and storage and the pharmaceutical development of drugs based on it.</p>

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Development of a Method for Determining Related Impurities in the Substance of ALM-802S, an Original Compound with Antiarrhythmic Activity

  • 期刊论文

  • 发表日期：

    2025年8月1日

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  • D. N. Kuznetsov,
  • L. N. Grushevskaya,
  • M. S. Sergeeva,
  • L. M. Gaevaya,
  • E. D. Denisenko,
  • V. L. Dorofeev

摘要

A high-performance liquid chromatography (HPLC) method for determining related impurities in the substance of ALM-802S, a new compound with antiarrhythmic activity, has been developed and validated. The developed method allows the detection of both process impurities and impurities of ALM-802S oxidation products with contents of less than 0.05% and the collection of data on the stability of the substance during its production and storage and the pharmaceutical development of drugs based on it.