过程开发
计算机科学
过程(计算)
铈替尼
可扩展性
工艺工程
程序设计语言
工程类
克里唑蒂尼
操作系统
医学
恶性胸腔积液
外科
胸腔积液
作者
Shravan Kumar Komati,Amarendhar Manda,Sridhar Vasam,Gopal Chandru Senadi,Arthanareeswari Maruthapillai,Rakeshwar Bandichhor
标识
DOI:10.1021/acs.oprd.4c00416
摘要
A convenient and commercially viable cost-effective, safe manufacturing process was developed to manufacture ceritinib. This work describes the implementation of the quality by design approach through the identification of critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs). Application of the statistical design of experimentation for an experimental plan to find the relationship between CQAs, CMAs, and CPPs. This work also describes a superior process for large-scale manufacturing of ceritinib in terms of process safety, handling, scalability, and enhanced throughput. Work captured here addressed the challenges in reported procedures such as sodium hydride's explosive hazard, high-temperature microwave conditions, nitro to amine reduction under high pressure using a palladium catalyst, and column chromatography to purify the finished product.
科研通智能强力驱动
Strongly Powered by AbleSci AI