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FORMULATIONS OF BENDAMUSTINE
专利权人:
Inc.;Eagle Pharmaceuticals
发明人:
Nagesh R. Palepu,Philip Christopher Buxton
申请号:
US15432335
公开号:
US20180000789A1
申请日:
2017.02.14
申请国别(地区):
US
年份:
2018
代理人:
摘要:
Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
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