PDF(Pubmed)
Abstract：
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.
摘要：
本文描述了系统的识别，合成，以及在tecovirimat的制造过程开发过程中使用的杂质控制方法，一种治疗猴痘的抗病毒药物.合成了关键杂质，通过核磁共振分析证实了它们的化学结构，GC,和HPLC质谱。结果建立了一个彻底的方法来识别，地址,并控制杂质，以根据国际协调会议（ICH）标准生产高质量的tecovirimat原料药。这项研究是首次评估tecovirimat中的过程和基因毒性杂质，在商业样品调查期间展示有效的控制措施，并扩大到60公斤的批量。研究结果强调了关键杂质表征和控制在药物开发和生产中的重要性，以确保最终产品的安全性和有效性。
