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Title:
ECHINOCANDIN DRUG IMPURITY, PREPARATION AND PURIFICATION METHOD THEREFOR AND APPLICATION THEREOF
Document Type and Number:
WIPO Patent Application WO/2023/035718
Kind Code:
A1
Abstract:
Disclosed are an echinocandin drug impurity, a preparation and purification method therefor and an application thereof. The echinocandin drug impurity has a structure represented by formula I: the echinocandin drug impurity is prepared by reacting micafungin sodium with an aqueous solution of protonic acid, followed by performing chromatography purification to obtain a high-purity echinocandin drug impurity. This addresses problems in the purification process such as the echinocandin drug impurity being extremely prone to degradation, and a high degree of difficulty of purification, obtaining an echinocandin drug impurity having an HPLC purity of 90% or more. The echinocandin drug impurity can be used as a reference substance for the establishment of analytical methods for the quality control of echinocandin drugs.

Inventors:
SHI RONGGUO (CN)
CHEN MIN (CN)
GUO YUSHAN (CN)
LI YAN (CN)
JI XIAOMING (CN)
Application Number:
PCT/CN2022/099564
Publication Date:
March 16, 2023
Filing Date:
June 17, 2022
Export Citation:
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Assignee:
SHANGHAI TECHWELL BIOPHARM CO (CN)
International Classes:
C07K7/56; C07K1/14; C07K1/16
Foreign References:
CN102627688A2012-08-08
CN102219832A2011-10-19
CN104861044A2015-08-26
CN105524144A2016-04-27
CN1604908A2005-04-06
CN113087774A2021-07-09
CN109734760A2019-05-10
US20050227914A12005-10-13
Other References:
OHIGASHI, A. ET AL.: "Process Development of Micafungin, a Novel Lipopeptide Antifungal Agent.", JOURNAL OF SYNTHETIC ORGANIC CHEMISTRY., vol. 64, no. 12, 31 December 2006 (2006-12-31), XP007920568, DOI: 10.5059/yukigoseikyokaishi.64.1294
Attorney, Agent or Firm:
SUNSHINE INTELLECTUAL PROPERTY INTERNATIONAL CO., LTD. (CN)
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