Analysis of Non-target Proteins in Human Albumin and Human Immunoglobulin by UHPLC-LTQ- Orbitrap-MS

ZHANG Hengjie; TANG Yao; WANG Juexiao; JIANG Jiaxing; LONG Lijuan; MA Jing; WANG Shuqiao; LI Yan; YANG Lei

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Analysis of Non-target Proteins in Human Albumin and Human Immunoglobulin by UHPLC-LTQ- Orbitrap-MS

VernacularTitle:UHPLC-LTQ-Orbitrap-MS分析人血白蛋白及人免疫球蛋白中非目标蛋白成分
Author: ZHANG Hengjie ¹ ; TANG Yao ¹ ; WANG Juexiao ¹ ; JIANG Jiaxing ¹ ; LONG Lijuan ¹ ; MA Jing ¹ ; WANG Shuqiao ¹ ; LI Yan ¹ ; YANG Lei ¹
Author Information

1. Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices), NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products, Chengdu 611731, China
Publication Type:Journal Article
Keywords: UHPLC-LTQ-Orbitrap-MS; blood products; non-target proteins; qualitative analysis; human albumin; human immunoglobulin
From: Chinese Journal of Modern Applied Pharmacy 2023;40(19):2713-2720
CountryChina
Language:Chinese
Abstract: OBJECTIVE To analyze and identify non-target proteins in human albumin and human immunoglobulin by ultra high performance liquid chromatography tandem linear ion trap orbitrap mass spectrometry. METHODS The extract was separated on a ACQUITY UPLC peptide BEH C18(300Å, 1.7 μm, 2.1 mm×100 mm) column and the gradient elution was performed with mobile phase consisting of 0.1% formic acid aqueous solution-0.1% formic acid acetonitrile. The analytes were detected in Full MS/dd-MS2(TopN). RESULTS A total of 52 non-target proteins were identified from human albumin and human immunoglobulin. Among them, 25 non-target proteins were identified in human albumin samples, and 27 non-target proteins were identified in human immunoglobulin samples. CONCLUSION The established qualitative method can rapidly, accurately and systematically identify various proteins in human albumin and human immunoglobulin. The results provide reference for the quality control of the preparation as well as its further clinical application.