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| 引用本文： | ��ӱ,����,��ұ,Ѧ��,����,�����. ͷ��������ˮ�����������о�[J]. 中国药学杂志, 2017, 52(18): 1639-1643. DOI: 10.11669/cpj.2017.18.017 |
| 作者姓名： | ��ӱ ���� ��ұ Ѧ�� ���� ����� |
| 作者单位： | 1. ?й????????о??,???? 100050; 2. ????????????????, ???? ???? 518110; 3. ?й?????,???? 100022 |
| 摘 要： | |
| 关 键 词： | ?????????????? ?????? ???л????? ??????ü??? |
Impurity Profile Study of Cefradine Dihydrate |
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| LIU Ying,SUN Xiao,TIAN Ye,XUE Jing,ZHU Feng-chang,HU Chang-qin. Impurity Profile Study of Cefradine Dihydrate[J]. Chinese Pharmaceutical Journal, 2017, 52(18): 1639-1643. DOI: 10.11669/cpj.2017.18.017 | |
| Authors: | LIU Ying SUN Xiao TIAN Ye XUE Jing ZHU Feng-chang HU Chang-qin |
| Affiliation: | 1. National Institutes for Food and Drug Control, Beijing 100050, China; 2. Shenzhen Zhijun Pharmaceutical Co. Ltd., Shenzhen 518110, China; 3. Chinese Pharmaceutical Association, Beijing 100022, China |
| Abstract: | ??OBJECTIVE To study the impurity profile of cefradine dihydrate. METHODS The impurity peaks of cefradine dihydrate were identified using column-switching technique and LC-MS, and the origination of the impurities were investigated by the forced degradation study.RESULTS The impurity profile of cefradine dihydrate included fourteen impurities, nine of them were structure known impurities controlled by EP, two of them were newly identified impurities and three of them were structure unknown impurities.CONCLUSION The origination and influence factors of the impurities are investigated though the impurity profile study of cefradine dihydrate, and it can provide reference for the quality control of cefradine dihydrate. |
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