不同来源的呋塞米原料杂质研究
Research on impurities in furosemide raw materials from different manufacturer sources
茅关兴 1赵丽敏 2丁溪影 1雷江 3尚越 3王英杰 3李琦君 3闫冬3
作者信息
- 1. 上海医药工业有限公司,上海 200002
- 2. 上海美优制药有限公司,上海 201400
- 3. 沈阳达善医药科技有限公司,辽宁沈阳 110179
- 折叠
摘要
目的 对不同厂家来源的呋塞米原料药进行晶型确证和杂质分析.方法 采用XPRD射线粉末衍射分析仪、高效液相色谱仪对呋塞米原料药进行分析.结果与结论 确认厂家A与厂家B的呋塞米原料药晶型与文献报道的晶型Ⅰ 一致.不同厂家生产的呋塞米原料药杂质类型和含量有所不同,注射级原料药的杂质个数和含量相对较低.研究结果对呋塞米产品的质量控制和临床用药安全具有重要意义.
Abstract
A study was conducted on the confirmation of crystal forms and impurity analysis of furosemide raw materials from different manufacturers.Using XPRD ray powder diffraction analyzer,it was confirmed that the crystal forms of furosemide raw materials from manufacture A and manufacture B were consistent with the reported crystal form Ⅰ.High-performance liquid chromatography analysis showed that there were differences in the types and contents of impurities in furosemide raw materials produced by different manufacturers,with injection-grade raw materials having relatively fewer impurities and lower contents.The research results are significant for controlling the quality of furosemide products and ensuring the safety of clinical medication use.
关键词
呋塞米/晶型/杂质分析/有关物质Key words
furosemide/crystal form/impurity analysis/related substance引用本文复制引用
出版年
2024
NETL
NSTL
万方数据