Title:
STABLE AST-3424 API PRODUCT, PREPARATION METHOD THEREFOR, AND STORAGE THEREOF
Document Type and Number:
WIPO Patent Application WO/2024/092614
Kind Code:
A1
Abstract:
Provided are a stable AST-3424 API product, a preparation method therefor, and storage thereof. The stable AST-3424 API product provided in the present invention is a solution of AST-3424 in ethanol, and the mass percentage of AST-3424 in the solution is 30%-40%. Also provided is a packaging unit of the product, which comprises a container and a stable AST-3424 API product contained in the container. The container is provided with a container body used for containing the product and a sealing structure used for sealing the container body. The container body and the sealing structure are both made from a medicinal-grade high-density polyethylene material. An oily AST-3424 product obtained after separation and purification is mixed with absolute ethyl alcohol at no more than 30 °C, and then distilled under reduced pressure until the mass percentage of AST-3424 reaches a preset value to obtain the product. The described product should be stored in a dark environment at -20 ± 5 °C.
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Inventors:
CAI XIAOHONG (CN)
RUAN MEIZHEN (CN)
DUAN JIANXIN (CN)
QU TONG (CN)
HUA SHIBIAO (CN)
CHEN TAO (CN)
LU ZHAOQIANG (CN)
RUAN MEIZHEN (CN)
DUAN JIANXIN (CN)
QU TONG (CN)
HUA SHIBIAO (CN)
CHEN TAO (CN)
LU ZHAOQIANG (CN)
Application Number:
PCT/CN2022/129548
Publication Date:
May 10, 2024
Filing Date:
November 03, 2022
Export Citation:
Assignee:
ASCENTAWITS PHARMACEUTICALS LTD (CN)
International Classes:
A61K9/08; A61K31/396; A61K47/10; A61P35/00
Foreign References:
| CN112220742A | 2021-01-15 | |||
| CN111568759A | 2020-08-25 |
Attorney, Agent or Firm:
SHANGHAI BILIPAT INTELLECTUAL PROPERTY AGENCY LTD. (CN)
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