USP泼尼松校正片说明书(中英文对照).docx

Certificate（证书）PREDNISONE TABLETS（泼尼松片）USP Catalog No.: 1559505USP Lot No.: R031Y1(10 mg nominal prednisone content per tablet)（每片含泼尼松10mg）FOR DISSOLUTION PERFORMANCE VERIFICATION TEST (PVT)用于溶出性能确认实验Period of validity: This certificate of USP Prednisone Tablets Lot R031Y1 is valid through June 30th, 2017.有效期：USP泼尼松片批号R031Y1的证书有效期到2017年6月30日The USP Prednisone Tablets RS is provided for use in the Performance Verification Test for USP Apparatus 1 and2 with 1liter vessels in the USP General Test Chapter on DISSOLUTION 711 and DRUG RELEASE 724, APPARATUSSUITABILITY. Store in a dry place. Store the tablets at controlled room temperature not exceeding 25°.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。Dissolution Medium: We recommend preparing the medium as follows:Heat a suitable amount of water, while stirring gently, to about 41-45°. Filter under vacuum through a 0.45-μm-porosityfilter into a suitable filtering flask equipped with a stirring device. Seal the flask and continue to apply vacuum whilestirring for an additional five minutes. Measured vacuum should be less than 100 mbar. The temperature of the Dissolutionmedium should not fall below 37° prior to the initiation of the test.溶出介质：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℃。真空下用0.45μm滤膜过滤至配有搅拌容器中（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100 mbar。在实验开始前溶出介质温度不高于37℃。Procedure：[See DISSOLUTION 711 in the current USP]: Determine the quantity of prednisone, C21H26O5, dissolvedat 30 minutes, in each vessel, expressed as percent of the labeled amount. Use 499 g of Dissolution Medium (whichcorresponds to 500 mL), where possible the medium should not be stirred prior to the initiation of the test for the purpose ofequilibration, and conduct the test at 37°. Operate each apparatus at 50- rpm speed. Withdraw an aliquot of sample solutionat 30 minutes and filter immediately. Measure the amount of prednisone dissolved from filtered portions of the samplealiquots at 242 nm in comparison with