Certificate(证书)ABLETS(泼尼松片)USPCatalogNo.:USPLotNo.:R031Y1(10mgnominalprednisonecontentpertablet)(每片含泼尼松10mg)FORDISSOLUTIONPERFORMANCEVERIFICATIONTEST(PVT)用于溶出性能确认实验Periodofvalidity:abletsLotR031Y1isvalidthroughJune30th,:abletsRSisprovidedforuseinthePerformanceVerificationTestforUSPApparatus1and2with1litervesselsintheUSPGeneralTestChapteronDISSOLUTION<711>andDRUGRELEASE<724>,°.USP泼尼松标准片用于采取USP中方法1和方法2对1升溶出杯,进行USP通用测试部分溶出(711)和释放(724)项目的性能能确认实验,药品贮藏在干燥,温度低于25℃环境中。DissolutionMedium:mendpreparingthemediumasfollows:Heatasuitableamountofwater,whilestirringgently,toabout41-45°.-μm-°:推荐介质准备(操作)如下:(脱气纯化水)加热适量水同时轻轻搅拌到约41~45℃。(即过滤后需要搅拌),密封容器口并继续在真空条件下搅拌5分钟。检测真空度小于100mbar。在实验开始前溶出介质温度不高于37℃。Procedure:[SeeDISSOLUTION<711>inthecurrentUSP]:hequantityofprednisone,C21H26O5,dissolvedat30minutes,ineachvessel,(whichcorrespondsto500mL),wherepossiblethemediumshouldnotbestirredpriortotheinitiationofthetestforthepurposeof
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