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<p>A high-performance liquid chromatography test procedure for determination of impurities in the drug substance of GIZH-272, a new compound with an anticonvulsant effect, was developed and validated. The proposed analytical procedure allowed technological impurities and impurities due to hydrolysis in acidic and alkaline media, oxidation, and photodegradation to be detected and stability data of the drug substance during its manufacture, storage, and pharmaceutical development of a drug product to be obtained.</p>

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Development of a Test Procedure for Determination of Impurities in GIZH-272, a New Compound with Anticonvulsant Effects

  • 期刊论文

  • 发表日期：

    2025年4月1日

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  • L. N. Grushevskaya,
  • M. S. Sergeeva,
  • L. M. Gaevaya,
  • N. M. Zaitseva,
  • M. I. Ustinova,
  • V. L. Dorofeev

摘要

A high-performance liquid chromatography test procedure for determination of impurities in the drug substance of GIZH-272, a new compound with an anticonvulsant effect, was developed and validated. The proposed analytical procedure allowed technological impurities and impurities due to hydrolysis in acidic and alkaline media, oxidation, and photodegradation to be detected and stability data of the drug substance during its manufacture, storage, and pharmaceutical development of a drug product to be obtained.