Full-Text Search:
Home|Journal Papers|About CNKI|User Service|FAQ|Contact Us|中文
《Chinese Journal of Blood Transfusion》 2016-01
Add to Favorite Get Latest Update

Qualification of method for the detection of polyethylene glycol residue in human coagulation factor Ⅷ products

LIU Wenwen;LIU Sufang;LU Kuilin;LIN Honghui;College of Life Science,Sichuan University;Chengdu Rongsheng pharmaceutical co. ,Ltd.;  
This paper qualifies the method used for analyzing polyethylene glycol( PEG) residue of human coagulation factor Ⅷ( FⅧ) according to Pharmacopoeia of the People's Republic of China( 2015 Edition)( 3 volumes). The accuracy,linearity,repeatability,range and intermediate precision met qualifications according to the The Verification Guidance of the Pharmaceutical Production( published in 2015). The results showed that the method meets the requirements. Therefore,the method can be used to detect the PEG content of human coagulation factor Ⅷ in Chengdu Rongsheng Pharmaceutical Co. The limit of quantification( LOQ) is determined at 2. 5μg / m L for PEG residual method. The detection range is 20 μg / m L- 50μg /m L.
【CateGory Index】: R927
Download(CAJ format) Download(PDF format)
CAJViewer7.0 supports all the CNKI file formats; AdobeReader only supports the PDF format.
【Co-citations】
Chinese Journal Full-text Database 4 Hits
1 GAO Guang-wei;LI Gui-lin;HUANG Jia-yu;LI Da-wei;School of Pharmacy,Shanghai Jiaotong University;;Study of the Effects of A and C-Domain Glycosylation Sites on the Secretion and Activity of Recombinant Factor Ⅷ[J];China Biotechnology;2014-10
2 JIANG Gui-xiang;ZHANG Wei;HONG Hao-wu;LV Ying-nian;Guangdong Shuanglin Bio-pharmaceutical Co.,Ltd.,The Engineering Center of Blood Products in Guangdong;;Progress in research on stability of human coagulation factor Ⅷ[J];Chinese Journal of Biologicals;2015-01
3 JIANG Gui-xiang;ZHANG Wei;ZHU Guang-zu;LV Ying-nian;Guangdong Shuanglin Bio-pharmaceutical Co. , Ltd. , the Engineering Center of Blood Products in Guangdong;;Effect of sodium chloride content on crystalline form of freeze-dried human coagulation factor Ⅷ[J];Chinese Journal of Biologicals;2015-02
4 DOU Zi;HE Yan-lin;Lanzhou Institute of Biological Products Co.,Ltd.,Center for Gansu Provincial Vaccine Engineering Research;;Progress on preparation of human coagulation factor Ⅷ[J];Progress in Microbiology and Immunology;2015-06
©2006 Tsinghua Tongfang Knowledge Network Technology Co., Ltd.(Beijing)(TTKN) All rights reserved