USP泼尼松校正片说明书中英文对照.pdfVIP

Certificate （证书） PREDNISONE TABLETS （泼尼松片） USP Catalog No.: 1559505 USP 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 and 2 with 1 liter vessels in the USP General Test Chapter on DISSOLUTION 711〉 and DRUG RELEASE 724〉， APPARATUS SUITABILITY。 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-porosity filter into a suitable filtering flask equipped with a stirring device 。 Seal the flask and continue to apply vacuum while stirring for an additional five minutes. Measured vacuum should be less than 100 mbar 。 The temperature of the Dissolution medium 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100mbar。 在实验开始前溶出介质温度不高于37℃. Procedure：［See DI OLUTION 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 (which corresponds to 500 mL）, where possible the medium should not be stirred prior to the initiation of the test for the purpose of equilibration,