Title:
METHOD FOR REFINING VALSARTAN COMPOUND
Document Type and Number:
WIPO Patent Application WO/2020/252662
Kind Code:
A1
Abstract:
The present application relates to a method for refining valsartan, which mainly removes nitrosamine impurities from valsartan. The specific method is: first dissolving valsartan in an organic solvent, washing using an acidic aqueous solution, and separating and removing an aqueous phase; next, forming valsartan into a salt in an organic solvent-water binary solvent system, then dissolving same in water, and separating and removing an organic phase; then, acidifying the aqueous phase to regenerate valsartan, adding an organic solvent to dissolve free valsartan, and separating and removing the aqueous phase; finally, drying the separated organic phase and then crystallizing same to obtain refined valsartan. The method provided in the present application is capable of efficiently eliminating the nitrosamine impurities from valsartan, and reducing the residual level thereof to less than 30 ppb.
Inventors:
WANG YIFENG (CN)
ZHU XIAOREN (CN)
ZHU YUANXUN (CN)
YAN FENGFENG (CN)
WAGN PENG (CN)
ZHU XIAOREN (CN)
ZHU YUANXUN (CN)
YAN FENGFENG (CN)
WAGN PENG (CN)
Application Number:
PCT/CN2019/091743
Publication Date:
December 24, 2020
Filing Date:
June 18, 2019
Export Citation:
Assignee:
ZHEJIANG HUAHAI PHARM CO LTD (CN)
ZHEJIANG HUAHAI TIANCHENG PHARMACEUTICAL CO LTD (CN)
ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO LTD (CN)
ZHEJIANG HUAHAI TIANCHENG PHARMACEUTICAL CO LTD (CN)
ZHEJIANG HUAHAI ZHICHENG PHARMACEUTICAL CO LTD (CN)
International Classes:
C07D257/04; A61P9/12
Foreign References:
| CN102093302A | 2011-06-15 | |||
| CN101362729A | 2009-02-11 | |||
| CN107056720A | 2017-08-18 | |||
| CN108896693A | 2018-11-27 | |||
| CN109060984A | 2018-12-21 |
Attorney, Agent or Firm:
PATENTSINO IP FIRM (CN)
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