Determination of polymer content in human albumin production process / 中国输血杂志
Chinese Journal of Blood Transfusion
;
(12): 909-913, 2021.
Artículo
en Chino
| WPRIM
| ID: wpr-1004444
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
Chinese Journal of Blood Transfusion
Año:
2021
Tipo del documento:
Artículo
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