Purity Determination and Stability Analysis of Human Epidermal Growth Factor Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.003
- VernacularTitle:基于国家药品抽检的人表皮生长因子纯度及稳定性分析
- Author:
Xinxin FANG
1
;
Hongrui YIN
1
;
Can WANG
1
;
Luxia ZHENG
1
;
Hong SHAO
1
Author Information
1. 上海市食品药品检验研究院,国家药品监督管理局治疗类单抗质量控制重点实验室,上海市创新生物制品质量检验检测中心,上海 201203
- Publication Type:Journal Article
- Keywords:
Human epidermal growth factor;
High performance liquid chromatography;
Purity determination
- From:
Herald of Medicine
2025;44(9):1385-1389
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high-performance liquid chromatography method to detect the purity of human epidermal growth factor(hEGF),to compare the stability of the products of different enterprises by purity results,and to provide technical support for improving quality control and unified monitoring of hEGF based on national drug sampling and testing.Methods Agilent 300SB C8 column(250 mm×4.6 mm,5 μm)was used.Mobile phase A was 7.5 mmol·L-1 sodium phosphate buffer(pH 6.8),and mobile phase B was acetonitrile,the column temperature was 30℃,the flow rate was 0.6 mL·min-1 with gradient elution,and the detector wavelength was set at 280 nm.Results The resolution between the main peak of hEGF and the adjacent impurity peak was more than 1.5,with a detection limit of 6 ng.This method has been successfully applied to determine the purity of the bulk and final products.The results showed that the purity of the final products decreased compared with the bulk.The maximum impurity that increased significantly was the deamidation impurity identified by the mass spectrometry.Conclusion Based on the typical sample of the full chain and multi-dosage form,the established method had good specificity and resolution for the preliminary identification and purity determination of hEGF bulk and final products.
