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Title:
PURIFICATION METHOD FOR SERTACONAZOLE NITRATE
Document Type and Number:
WIPO Patent Application WO/2023/004914
Kind Code:
A1
Abstract:
A purification method for sertaconazole nitrate, which is used for preparing a sertaconazole nitrate crystal form with a melting point of 156-161°C. The purification method comprises: (1) mixing a crude product of sertaconazole nitrate with 95% ethanol, then raising the temperature to reflux; (2) adding activated carbon, then continuing to reflux; (3) after reflux finishes, filtering to remove the activated carbon so as to obtain a filtrate; (4) adding water dropwise to the obtained filtrate while stirring to precipitate a crystal; and (5) after dropwise addition is complete, filtering the crystal and then drying. After using 95% ethanol to heat and dissolve the crude product of sertaconazole nitrate, water is added dropwise to dissolve and crystallize same; it was unexpectedly found that a crystal form of sertaconazole nitrate with a melting point of 156-161°C can be obtained. The melting point of the crystal form meets requirements of the European Pharmacopoeia or the British Pharmacopoeia, which provides technical support for exporting the drug to these countries and regions.

Inventors:
LIU YU (CN)
WEI JIAHUA (CN)
LI BOFU (CN)
Application Number:
PCT/CN2021/114842
Publication Date:
February 02, 2023
Filing Date:
August 26, 2021
Export Citation:
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Assignee:
HAINAN HAISHEN TONGZHOU PHARMACEUTICAL CO LTD (CN)
International Classes:
C07D409/12
Foreign References:
CN1358719A2002-07-17
EP0151477A21985-08-14
CN101022727A2007-08-22
Other References:
VENKATESWARLU RAYUDU S.; KUMAR P.: "An Easy, Efficient and Improved Synthesis of Sertaconazole Nitrate", RUSSIAN JOURNAL OF ORGANIC CHEMISTRY, M A I K NAUKA - INTERPERIODICA, RU, vol. 55, no. 8, 1 August 2019 (2019-08-01), RU , pages 1212 - 1216, XP036901417, ISSN: 1070-4280, DOI: 10.1134/S1070428019080219
Attorney, Agent or Firm:
INTELIGHT IP LAW FIRM (CN)
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