多克尺度合成和表征莫马塔松酸EP不纯度C
Riccardo Ronchetti1, Luigi Alfonso Pannone1, Bruno Cerra1
1Laboratory of Medicinal and Advanced Synthetic Chemistry (Lab MASC), Department of Pharmaceutical Sciences, University of Perugia, Via del Liceo 1, 06122 Perugia, Italy.
Molecules (Basel, Switzerland)
|December 9, 2023
概括
本研究详细介绍了Mometasone Furoate EP Impurity C的多克制剂,这是分析方法开发和毒理学研究的关键化合物. 该研究还研究了其合成中的关键中间体和反应步骤.
科学领域:
- 制药化学 制药化学 制药化学
- 有机合成 有机合成
- 分析化学 分析化学
背景情况:
- 莫马塔松酸是一种合成皮质类固醇,广泛用于炎症状况.
- 工业合成的mometasone furoate产生的过程杂质需要检测和量化.
- 纯杂质的可用性对于合规性至关重要,包括毒理学研究和分析方法验证.
研究的目的:
- 报告Mometasone Furoate EP杂质C的多克制备情况.
- 为了研究杂质C的合成路径和关键中间体.
- 为制药品质量控制提供可靠的C杂质来源.
主要方法:
- 多克尺度有机合成.
- 对乙化反应的研究.
- 化学中间体的表征.
- 净化和隔离技术. 净化和隔离技术.
主要成果:
- 在多克尺度上成功合成了莫马塔松酸EP不纯度C.
- 系统地调查最后一个乙化步骤.
- 二酸乙醇中间体的表征.
- 将转化途径变为杂质C. 的解.
结论:
- 报告的合成途径使得可靠的,大规模的准备Mometasone Furoate EP不纯度C.
- 这项工作为制药行业提供了必要的材料,以确保mometasone furoate的质量和安全性.
- 了解杂质合成对于稳健的工艺开发和监管遵守至关重要.
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