发明名称 |
HIGH PURITY ORITAVANCIN AND METHOD OF PRODUCING SAME |
摘要 |
Drug substance preparations of oritavancin having high purity are disclosed, along with pharmaceutical compositions comprising such oritavancin drug substance preparations, and drug products or dosage forms comprising such pharmaceutical compositions. |
申请公布号 |
US2016015772(A1) |
申请公布日期 |
2016.01.21 |
申请号 |
US201514801303 |
申请日期 |
2015.07.16 |
申请人 |
The Medicines Company |
发明人 |
Rafai Far Adel;Krishna Gopal;Ding Min;Chemburkar Sanjay R.;Knable Carl M.;Petzel James J.;Pruyne Julie J.;Reamer Douglas M. |
分类号 |
A61K38/08 |
主分类号 |
A61K38/08 |
代理机构 |
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代理人 |
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主权项 |
1. A pharmaceutical composition comprising an oritavancin drug substance preparation and one or more pharmaceutically acceptable excipients, wherein the oritavancin drug substance preparation has about 90% purity or greater by peak area relative to impurities 2-16, defined by peaks B-P of FIG. 2, respectively. |
地址 |
Parsippany NJ US |