Invention Grant
- Patent Title: Pure vancomycin hydrochloride
- Patent Title (中): 纯万古霉素盐酸盐
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Application No.: US11720893Application Date: 2005-12-05
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Publication No.: US08435938B2Publication Date: 2013-05-07
- Inventor: Rok Grahek , Andrej Bastarda
- Applicant: Rok Grahek , Andrej Bastarda
- Applicant Address: unknown Ljubljana, Slovenia
- Assignee: Lek Pharmaceuticals d.d.
- Current Assignee: Lek Pharmaceuticals d.d.
- Current Assignee Address: unknown Ljubljana, Slovenia
- Agency: Luedeka Neely Group, P.C.
- Priority: SIP200400334 20041207
- International Application: PCT/EP2005/012998 WO 20051205
- International Announcement: WO2006/061166 WO 20060615
- Main IPC: A61K38/04
- IPC: A61K38/04 ; A61K38/12 ; C07K7/54

Abstract:
The new pure vancomycin hydrochloride substantially free of impurities known in commercially available products is described. The term “substantially free of impurities” designates a purity of vancomycin hydrochloride between about 97% and about 99%, particularly between about 98% and about 99%, preferably about 99%, as determined by HPLC analytical method as directed in U.S.P., NF 27th revision, 22 (2004). The new pure vancomycin hydrochloride (vancomycin B hydrochloride) contains less than 0.7% of total impurities, namely, only one impurity exceeds 0.3%. The new process for the purification of crude vancomycin by displacement chromatography is described by which the desired pure antibiotic according to the present invention is produced, based on the finding that high purity of the vancomycin hydrochloride is obtained using low selected pH values of the mobile phase between 3.9 and 4.2. Vancomycin hydrochloride is the known antibiotic which is used for the treatment of severe staphylococcal infections, especially those caused by methicillin-resistant staphylococcal strains.
Public/Granted literature
- US20100190958A1 PURE VANCOMYCIN HYDROCHLORIDE Public/Granted day:2010-07-29
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