Determination of polymer content in human albumin production process
10.13303/j.cjbt.issn.1004-549x.2021.08.029
- VernacularTitle:人血白蛋白生产过程中多聚体含量的检测
- Author:
Zi DOU
1
;
Xiaojie ZHAO
1
;
Qiming ZHANG
1
;
Xingye ZHU
1
;
Jipeng ZHANG
1
;
Xiao LIU
1
Author Information
1. Lanzhou Lansheng Plasma-derived Biotherapies Co., Ltd. Lanzhou 730046, China
- Publication Type:Journal Article
- Keywords:
human albumin;
polymer;
high performance liquid chromatography;
quality control
- From:
Chinese Journal of Blood Transfusion
2021;34(8):909-913
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To study the quality control of human albumin intermediates content in production process using High Performance Liquid chromatography (HPLC) method. 【Methods】 In accordance with the general principles of The Chinese Pharmacopoeia (2015 edition), 3121 human albumin polymer was used to determine the component V precipitation solution, human albumin stock solution, human albumin semi-finished products and human albumin products in the production process of human albumin. The chromatographic retention time and the chromatographic peak area percentage corresponding to the retention time were analyzed. 【Results】 The polymer content of component V precipitation solution, human albumin stock solution, human albumin semi-finished products, and human albumin products were was 0.2% vs 0.0% vs 1.9% vs 1.7%, 0.2% vs 0.0% vs1.8% vs1.5% and 0.1% vs 0.0% vs 1.6% vs 1.5%, respectively. 【Conclusion】 HPLC can be used as a monitoring method for human albumin production.
