Impurity study of tecovirimat
文献类型：期刊论文
| 作者 | Bonku, Emmanuel Mintah3,4; Qin, Hongjian2,4; Odilov, Abdullajon3,4; Abduahadi, Safomuddin3,4; Guma, Samuel Desta3,4; Yang, Feipu4; Xing, Xinglong1; Wang, Xukun1; Shen, Jingshan3,4
|
| 刊名 | HELIYON
 |
| 出版日期 | 2024-05-15 |
| 卷号 | 10期号:9页码:12 |
| 关键词 | Tecovirimat Genotoxic impurities Process development International Conference on Harmonization (ICH) Quality control |
| DOI | 10.1016/j.heliyon.2024.e29559 |
| 通讯作者 | Xing, Xinglong(xinglong.xing@vigonvita.cn) ; Shen, Jingshan(shenjingshan@simm.ac.cn) |
| 英文摘要 | This article delineates the systematic identification, synthesis, and impurity control methods used during the manufacturing process development of tecovirimat, an antiviral drug that treats monkeypox. Critical impurities were synthesized, and their chemical structure was confirmed through NMR analysis, GC, and HPLC mass spectrometry. The results established a thorough approach to identify, address, and control impurities to produce high -quality tecovirimat drug substance in accordance with International Conference on Harmonization (ICH)-compliant standards. This study is the first of its kind to evaluate both process and genotoxic impurities in tecovirimat, demonstrating effective control measures during commercial sample investigations and scaling up to a 60 -kg batch size. The findings highlight the importance of critical impurity characterization and control in pharmaceutical development and production to ensure the safety and efficacy of the final product. |
| WOS关键词 | CYCLOADDITION REACTIONS ; CYCLOHEPTATRIENE ; COMPLEXES |
| 资助项目 | Institute of Drug Innovation of the Chinese Academy of Sciences[CASIMM120234003] ; China-Uzbekistan New Drug, Belt and Road Joint Laboratory Construction and Innovative Drug Research for National Key R &D Program of China[2020YFE0205600] ; University of Chinese of Sciences for the UCAS |
| WOS研究方向 | Science & Technology - Other Topics |
| 语种 | 英语 |
| WOS记录号 | WOS:001246418500001 |
| 出版者 | CELL PRESS |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/311935]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Xing, Xinglong; Shen, Jingshan |
| 作者单位 | 1.Vigonvita Life Sci Co Ltd, 108 Yuxin Rd,Suzhou Ind Pk, Suzhou 215123, Jiangsu, Peoples R China 2.Chinese Acad Sci, Xinjiang Tech Inst Phys & Chem, State Key Lab Basis Xinjiang Indigenous Med Plants, Urumqi 830011, Xinjiang, Peoples R China 3.Univ Chinese Acad Sci, 19A Yuquan Rd, Beijing 100049, Peoples R China 4.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, 555 Zuchongzhi Rd, Shanghai 201203, Peoples R China |
| 推荐引用方式 GB/T 7714 | Bonku, Emmanuel Mintah,Qin, Hongjian,Odilov, Abdullajon,et al. Impurity study of tecovirimat[J]. HELIYON,2024,10(9):12. |
| APA | Bonku, Emmanuel Mintah.,Qin, Hongjian.,Odilov, Abdullajon.,Abduahadi, Safomuddin.,Guma, Samuel Desta.,...&Shen, Jingshan.(2024).Impurity study of tecovirimat.HELIYON,10(9),12. |
| MLA | Bonku, Emmanuel Mintah,et al."Impurity study of tecovirimat".HELIYON 10.9(2024):12. |
入库方式： OAI收割
来源：上海药物研究所
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