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Assays for the Identification of Novel Antivirals against Bluetongue Virus
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Impurity study of tecovirimat.

Emmanuel Mintah Bonku1,2, Hongjian Qin1,3, Abdullajon Odilov1,2

  • 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zuchongzhi Road, Shanghai, 201203, PR China.

Heliyon
|May 14, 2024
PubMed
Summary
This summary is machine-generated.

This study details impurity control for tecovirimat, an antiviral for monkeypox. Effective methods ensure high-quality drug substance production, meeting global pharmaceutical standards.

Keywords:
Genotoxic impuritiesInternational Conference on Harmonization (ICH)Process developmentQuality controlTecovirimat

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Area of Science:

  • Pharmaceutical Manufacturing
  • Analytical Chemistry
  • Antiviral Drug Development

Background:

  • Tecovirimat is a critical antiviral medication for treating monkeypox.
  • Ensuring drug purity and safety is paramount in pharmaceutical manufacturing.
  • Process and genotoxic impurities require rigorous identification and control.

Purpose of the Study:

  • To systematically identify, synthesize, and control impurities during tecovirimat manufacturing.
  • To establish ICH-compliant standards for tecovirimat drug substance quality.
  • To evaluate impurity control for commercial samples and large-scale production.

Main Methods:

  • Synthesis of critical impurities.
  • Structural confirmation using Nuclear Magnetic Resonance (NMR) analysis.
  • Chromatographic and mass spectrometric techniques (GC, HPLC-MS).

Main Results:

  • A comprehensive approach for impurity identification and control was established.
  • Chemical structures of critical impurities were confirmed.
  • Effective impurity control was demonstrated for commercial samples and up to a 60-kg batch size.

Conclusions:

  • The study provides a robust framework for impurity characterization and control in tecovirimat production.
  • Adherence to ICH standards ensures the quality and safety of the tecovirimat drug substance.
  • This work is the first to assess both process and genotoxic impurities in tecovirimat manufacturing.