Full
Outline
This article provides an in-depth exploration of the current quality control status and regulatory developments concerning ethylene glycol, diethylene glycol, and triethylene glycol impurities in pharmaceutical excipients. Since the 1940s, global public safety incidents caused by the misuse or contamination of ethylene glycol or diethylene glycol have occurred frequently, drawing significant attention from regulatory authorities worldwide. Regulatory agencies have introduced corresponding measures to prevent the recurrence of such incidents. The article details the sources, uses, safety profiles of ethylene glycol, diethylene glycol, and triethylene glycol, as well as their respective pharmacopoeial standards and the current regulatory landscape. Testing for the presence of these three impurities in representative excipient products has revealed potential risks posed by ethylene glycol, diethylene glycol, and triethylene glycol in pharmaceutical excipients. Based on these findings, the article proposes recommendations for strengthening detection standards, enhancing regulatory oversight, and improving safety assessments to ensure the safety of pharmaceutical excipients and prevent similar pharmaceutical disasters. The results indicate that establishing rigorous detection methods and standards for these three impurities is crucial for ensuring the overall quality and safety of pharmaceuticals, especially in the quality control of excipients, which should be given equal importance as that of active pharmaceutical ingredients.
27
5
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62662699(Operation and Technical Support)
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
