Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (1): 52-56.
DOI: 10.19803/j.1672-8629.2022.01.11

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Development of the first national reference substance of favipiravir as a candidate drug against COVID-19

XIONG Jing, YAN Jing, LIU Yi, LIU Yang, HE Lan*   

  1. National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China
  • Received:2021-05-14 Online:2022-01-15 Published:2022-01-20

Abstract: Objective To establish the first national reference standard for content determination of favipiravir in order to ensure the quality of favipiravir tablets. Methods MS, 1H-NMR, 13C-NMR, and FTIR were used to confirm the structure. HPLC was used to analyze the related substances, uniformity and stability of favipiravir. Other physical and chemical properties were examined by GC, water determination, dynamic vapor sorption(DVS) and residue on ignition test. The content was assigned using the mass balance method and verified by 19F-NMR, HPLC, DSC. Results The structure of the national reference substance for favipiravir was confirmed, and the content was 99.7%. Conclusion The first national reference substance for favipiravir is characterized by high purity, good accuracy and stability, which can effectively control the quality of this product.

Key words: favipiravir, COVID-19, reference substance, reference standard, mass balance method, quantitative nuclear magnetic resonance, DVS

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