Quantitative Analysis of Residual EDTA in Vaccine Products by HPLC with Luminescence Detection of Terbium(III) Complexation

Autor:	Richard R. Rustandi, Yang Wang, Michael W. Washabaugh
Rok vydání:	2005
Předmět:	Detection limit Chromatography Clinical Biochemistry Pharmaceutical Science chemistry.chemical_element Terbium EDTA Clearance Reversed-phase chromatography Biochemistry High-performance liquid chromatography Analytical Chemistry chemistry Chelation Luminescence Quantitative analysis (chemistry)
Zdroj:	Journal of Liquid Chromatography & Related Technologies. 28:2645-2654
ISSN:	1520-572X 1082-6076
DOI:	10.1080/10826070500222801
Popis:	To facilitate the investigation of EDTA clearance in a protein purification process, a relatively simple, sensitive, and rapid method for EDTA analysis was developed using HPLC with pre‐column complexation of EDTA and terbium(III) (Tb3+). The limit of detection of this method is about 87 ng/mL, and the limit of quantitation is about 260 ng/mL. The accuracy, intra‐ and inter‐assay variability of this method were evaluated. The method was applied to determine the residual EDTA concentrations in various stages of the purification process for vaccine products. Examples of evaluating EDTA clearance in a protein purification process will be discussed.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::a07b13c059b544dfe94db656b79a2fee https://doi.org/10.1080/10826070500222801 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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