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Title:
METHOD FOR REMOVING GAS-PHASE IMPURITIES IN SUGAMMADEX SODIUM, AND METHOD FOR PREPARING AMORPHOUS SUBSTANCE THEREOF
Document Type and Number:
WIPO Patent Application WO/2019/184773
Kind Code:
A1
Abstract:
The present invention discloses a method for removing gas-phase impurities in Sugammadex sodium. The method comprises steps such as water dissolvation, distillation, drying and the like in mild conditions, and is suitable for mass production. The number and content of the gas-phase impurities in Sugammadex pure sodium product prepared herein are superior to those in a previously developed product. The present invention further discloses a method for preparing an amorphous Sugammadex sodium having high product stability and suitable for production.

Inventors:
LI, Faguang (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
GAO, Hong (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
LIU, Qun (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
HOU, Yunze (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
XIAO, Yu (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
BAI, Junpeng (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
MENG, Qiuyue (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
YANG, Guang (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
QI, Haofei (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
WANG, Qianqian (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin, CN)
WANG, Zheng (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
HE, Xiaoxia (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
HU, Baiyan (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
HUO, Xianghong (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
WANG, Qi (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
WANG, Lichun (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
WANG, Jingyi (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
Application Number:
CN2019/078808
Publication Date:
October 03, 2019
Filing Date:
March 20, 2019
Export Citation:
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Assignee:
TIANJIN KELUN PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD. (15th Floor, Room N1505 Tianjin International Joint Academy Of Biomedicine, No. 220 Dongting Road, TEDA, Tianjin 7, 300457, CN)
International Classes:
C08B37/16; A61K31/724; A61P21/00
Domestic Patent References:
WO2014125501A12014-08-21
Foreign References:
CN109053933A2018-12-21
CN107686530A2018-02-13
CN101712972A2010-05-26
Attorney, Agent or Firm:
ZHONGZI LAW OFFICE (7F New Era Building, 26 Pinganli Xidajie Xicheng,District, Beijing 4, 100034, CN)
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