Michael G. Parker,Scott S. Wilson,Yasmeen Chahal,Kelly W. Hovius,David E. McAnany
申请号：
US15355868
公开号：
US20170143719A1
申请日:
2016.11.18
申请国别(地区):
US
年份:
2017
代理人:
摘要：
Stable phenobarbital sodium solutions for injection that do not generate impurities during extended storage. These solutions include phenobarbital sodium in an amount of 15 to 200 mg/mL a C1-C4 alcohol such as ethanol in an amount of 105 to 160 mg/mL and a glycol such as propylene glycol in an amount of between 620 and 830 mg/mL and have a pH of between 9 and 12 which is adjusted to that range by adding acid or base, as required. No more than 50 mg/mL water is present including any water introduced by the acid or base. The solutions contain no more than 0.8% of phenyl ethyl acetyl urea impurity as well as no detectable amount of phenyl butyric acid after two years storage at room temperature.
