Addtime:2023-08-28 Hit: 835
CAS number: 3055-99-0
CDE registration number: Y20210000529(A)
Pharmacopoeia specification compliance: EP/JP
Storage conditions: In an airtight container, protected from light, at 2 ~ 8 ℃.
Properties and Benefits
l First registration in China.
l Meet the specifications of EP and JP.
l Using precise polymerization technology to ensure the high repeatability of structural characteristics such as the average chain length of the product and the average polymerization degree of ethylene oxide.
l Strictly control the impurity level of starting raw materials, and adopt advanced refining and processing technology to ensure that the impurities content of the product meets the requirements of the ICH guidelines for APIs.
l Complete evaluation, research and control of mutagenic impurities to ensure drug safety.
l Investigate and control elemental impurities according to ICH Q3D guidelines.
l The accelerated and long-term stability tests indicated good stability of the products
Applications
l Active pharmaceutical ingredients, Sclerosing Agents.