Quality study of pharmaceutical excipient polysorbate 80
10.11665/j.issn.1000-5048.20200206
- VernacularTitle:药用辅料聚山梨酯80的质量研究
- Author:
Chenchen YI
1
;
Ruilin SHA
;
Qinying CHEN
;
Yerong XIONG
;
Jiasheng TU
Author Information
1. 中国药科大学药学院，药用辅料及仿创药物研发评价中心
- Publication Type:Journal Article
- Keywords:
polysorbate 80;
quality standards;
gas chromatography;
infrared spectroscopy
- From:
Journal of China Pharmaceutical University
2020;51(2):168-174
- CountryChina
- Language:Chinese
-
Abstract:
To improve the current quality standards of polysorbate 80 and provide reference recommendations for the revision of the quality standards of polysorbate 80 in the fourth part of China Pharmacopoeia(2015 Edition). A total of 16 batches of polysorbate 80 samples from 6 domestic and foreign production companies were studied, optimize the detection method for some impurities. Adjust the split ratio of the ethylene oxide and dioxane check items, and appropriately increase the concentration of the reference solution solution and change the solvent. In the ethylene glycol and diethylene glycol items, the concentration of the reference solution and the internal standard solution were appropriately increased. The infrared identification and the triethylene glycol check items were added to the quality standards, and we carry out corresponding methodological investigation on the improved method. The results showed that the improved methods had good specificity, precision, linearity and recovery rate. The improved quality standard is more suitable for the detection of polysorbate 80, and can increase the quality standards of polysorbate 80 from safety and standardization.
