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FORMULATIONS OF BENDAMUSTINE
专利权人:
发明人:
申请号:
EP13749829.1
公开号:
EP2814487A1
申请日:
2013.02.14
申请国别(地区):
EP
年份:
2014
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 contains a mixture of PEG and PG an organic or inorganic compound in an amount sufficient to obtain a pH of from about 6.0 to about 11 for the polyethylene glycol, as measured using USP monograph for polyethylene glycol and optionally an antioxidant. The bendamustine-containing compositions have less than about 5% total esters, 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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