硫普罗宁注射液其他杂质的结构分析  

Structure identification of the other impurities in tiopronin injection

作　　者：黄静[1] 黄海伟[2] 张启明[2] 杭太俊[3] 

机构地区：[1]河北省药品检验所,石家庄050011 [2]中国食品药品检定研究院,北京100050 [3]中国药科大学药物分析教研室,南京210009

出　　处：《药物分析杂志》2012年第4期643-646,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:确证硫普罗宁注射液中2个较大杂质的结构。方法:利用HPLC和LC-MS等方法确证结构。结果:确证两未知杂质结构为:2-巯基丙酸和N-(2-氯丙酰基)-甘氨酸。结论:2个杂质的结构确定,为硫普罗宁生产工艺的改进及选择合适的运输、储存条件提供了重要信息。Objective：To elucidate two impurities in tiopronin injections.Method：two related impurities were identified with HPLC and LC-MS.Results：Two unknown impurities were confirmed to be 2-mercaptopropionic acid and N-（2-chloro carbonyl）-glycine.Conclusion：Confirmed the structure of two impurities,provide important information for the production process of tiopronin improvements and the selection of the appropriate transport and storage conditions.

关 键 词：硫普罗宁注射液 杂质鉴定 结构确证 生产工艺 液相色谱-质谱联用 

分 类 号：R917[医药卫生—药物分析学]