摘要
目的讨论用于HIV-1感染治疗药物——阿扎那韦的质量控制关键属性。方法从阿扎那韦制备工艺入手,对其各个环节可能引入的杂质进行分析。结果与结论确定在生产工艺过程中可能引入的杂质以及成品中可能残存的有机溶剂,从而得出阿扎那韦质量标准中所需控制的关键点。
Objective To determine the key attributes of atazanavir quality control, which is used for treating HIV-1. Methods Based on the preparation process of atazanavir, possible impurities introduced during the production procedures were analyzed. Results and Conclusion Impurities and remaining organic solvents were determined, from which the key attributes in atazanavir quality standards were drawn.
出处
《中国药事》
CAS
2014年第4期413-417,共5页
Chinese Pharmaceutical Affairs
关键词
阿扎那韦
质量标准
生产工艺
atazanavir
quality standard
production process
