Application of UPLC/VION Mass Spectrometry in Quality Control of Recombinant Human Albumin
WANG Min-li1, ZHANG Qian-qian2, WANG Hui2, SONG Lan-kun2*, HOU Ji-feng1*
1. National Institutes for Food and Drug Control, WHO Collaboration Center for Standardization and Evaluation of Biologicals, Beijing 100050, China; 2. Waters Technologies Shanghai Co. Ltd., Shanghai 201206, China
Abstract��OBJECTIVE To evaluate the applicability of UPLC/MS method for the identification test of human serum albumin (HSA) products including plasma derived and recombinant HSA samples.METHODS ACQUITY UPLC with Vion IMS QTof LC/MS system was used combined with on-line HSA sample desalting with ACQUITY UPLC BEH C18 column. The acquired multiply-charged mass spectrum was processed with MaxEnt1 automatic protein deconvolution software in UNIFI, which can transfer the raw mass spectrometry data to zero charge molecular mass or mass distribution of the intact protein.RESULTS Intact protein mass analysis not only provided the accurate mass of HSA, but also provided an overall view of the heterogeneity of HSA and the relative amounts of various forms. From this study, a very specific mass signal ��(66 437��1), which is the theoretical average MW of human serum albumin�� was obtained from all the six HSA samples. And the characteristic spectra of different samples were also got.CONCLUSION UPLC/MS method has very good specificity and high sensitivity and can distinguish HSA products made by different manufacturers and processes. The total analytical time is 10 min, which is ideal for the QC identification test of HSA products.
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WANG Min-li, ZHANG Qian-qian, WANG Hui, SONG Lan-kun, HOU Ji-feng. Application of UPLC/VION Mass Spectrometry in Quality Control of Recombinant Human Albumin. Chinese Pharmaceutical Journal, 2018, 53(9): 729-738.
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2018, Vol. 53 
