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Study on methods and requirements for quality control of Pegylated Erythropoietin(PEG-EPO)

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Objective: To establish methods and requirements for the quality control of PEG-EPO. Methods: In vivo bioactivity of PEG-EPO was determined by the count of reticulocytes in normocythaemic mice.Isoforms were analyzed by cIEF.Oligosaccharide fingerprint profiling was determined by HPAEC.Purity and peptide mapping were analyzed by reverse HPLC system.Other routine tests were all carried out according to the Chinese pharmacopoeia(volume ,2010 edition). Results: The requirements and methods for the quality control of PEG-EPO have been established.The results of all tests were reliable and reproducible,and complied with the Chinese pharmacopoeia and guidelines for the quality control of recombinant DNA products. Conclusion: The methods and requirements for PEG-EPO showed the characteristics of assuring the products safety and efficacy,which can be used for the quality control of PEG-EPO.

PLEASE NOTE: The full text of this publication is in Chinese.

Keywords: RP-HPLC; bioactivity; capillary isoelectric focusing electrophoresis; erythrometry; ion chromatography; oligosaccharide fingerprint; pegy-lated erythropoietin; peptide mapping

Document Type: Research Article

Publication date: 01 January 2012

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  • Journal of Pharmaceutical Analysis is a professional journal administrated by China Association for Science and Technology, sponsored by Chinese Pharmaceutical Association, held by National Institutes for Food and Drug Control, edited and published by the Editorial Board of Journal of Pharmaceutical Analysis, and publicly distributed at home and abroad. It is one of the first group of journals that created by academic leaders in the field of drug control. It originated from Drug Control Communication which magazine was founded in 1951 and later been renamed in 1981. In 2005, it was changed from bi-monthly journal to monthly journal. Journal of Pharmaceutical Analysis is among core journals in nature sciences and even other Chinese core journals, whose main columns are research reports, communications, review, forum, information and etc. It mainly reports the latest research results, explore new theories, introduce new development, spread new techniques, and promote new methods of pharmaceutical analysis. Its contents include peer-reviewed research reports, research presentation and summary reviews on all aspects of pharmaceutical analysis including drug development, pharmaceutical manufacturing, clinical research, drug safety, quality assessment, and market surveillance. Main authors and target reader are professional and technical personnel engaged in research, application as well as higher education in pharmaceutical analysis.
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