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《Chinese Journal of Blood Transfusion》 2016-01
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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
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