机场购物Certificate割肉相啖（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 u in the Performance Verification Test for USP Apparatus 1 and 2 with 1 liter vesls in the USP General Test Chapter on DISSOLUT
ION <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41～45operators℃。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 vesl, expresd as percent of the labeled amount. U 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 purpo of equilibration, and conduct the test at 37°. Operate each apparatus at 50- rpm speed. Withdraw an aliquot of sample solution at 30 minutes and filter immediately. Measure the amount of prednisone dissolved from filtered portions of the sample aliquots at 242 nm in comparison with a solution of known concentration of USP Prednisone Reference Standard.
公证处英文
步骤：［查看USP现行版的溶出〈711〉］：确定泼尼松数量，每个溶出杯中溶解30分钟，结果用百分比表示。499g溶出介质（相当于500ml溶出介质），为了达到溶出介质平
衡，实验开始前不能搅拌溶出介质并且温度控制37℃。开启转速50转。30分钟时取样马上过滤。在242nm波长下测定溶出度（百分比表示）与已知浓度的USP泼尼松参考标准比较。
实验条件：500ml溶出介质、37℃、50转/分钟、30分钟取样
检测： 242nm的波长下测定供试品溶液和对照品溶液的溶出度
Note: An amount of alcohol not to exceed 5% of the total volume of the standard solution may be ud to bring the prednisone reference standard into solution.The filtering method must not cau absorptive loss of drug.Bras introduced by automated methods is to be avoided.If equipment is dedicated for u with only one apparatus (basket or paddie).then performance verification is only required for that apparatus.At the time of u ,peel back the paper-backed lidding to remove the tablets from the blister card
注意mia ro：
1、乙醇的用量应不超过总体积的 1％。（对照品先用少量乙醇溶解以加快溶解速度）；
2、自动取样系统可以减少偏差；
3、如果只仪器只用一种方法（转篮或桨板），仅仅需要对使用的方法进行确认；
est Interpretation: Laboratory can choo either of the test schemes listed below.
实验说明：从以下实验方案中选择一种
Single-Stage Test
单阶实验：
The following are step-by-step instructions for the Single-Stage test.
单阶实验操作步骤：
过去式单词1. For each position in the asmbly, test one USP Prednisone Tablets RS, and record the percent dissolved at the sampling time point specified. Transform the percent dissolved results to the natural log scale, determine the mean and variance. For asmbli
es with 12 or 14 positions (12 or 14 dissolution vesls), no further testing is required.
1.每个溶出杯中放入一粒USP泼尼松片，按照选取方法在规定时间点取样并检测溶出度。先将各个溶出度数据计算得到自然对数，再以自然对数为数据，计算其平均数（）和方差（）,12个和14个溶出杯的仪器可以不再进行后续检测。
2. For asmblies with fewer than 12 positions, repeat Step 1 with an additional t of tablets. Again after transforming the percent dissolved results to the natural log scale, determine the mean and variance.
2. 不到12个溶出杯的仪器，重复第1步操作，即再次向每个溶出杯中放入一粒USP泼尼松片，按照选取方法在规定时间点取样并检测溶出度。将检测得到的各个溶出杯结果计算平均数（）和方差（nsation是什么意思）
3. Calculate the average of the two means and of the two variances obtained in Steps 1 and 2. (U the results from Step 1 alone for asmblies that have 12 or 14 positions.)
3．将第1、2步中得到的两个平均值（、）和方差（sob、）分别计算各自的平均值。
即，，（12个或者14个溶出杯无需计算，直接取用第1步计算结果，即==）
4. Convert the results of Step 3 to a geometric mean (GM) and percent coefficient of variation (%CV). See calculation example below for more detail.
4.第3步中计算得到的和按照以下公式计算得到GM和%CV。
modernwarfare5. Compare the results of Step 4 to the Single-Stage acceptance ranges in Table 1. The GM must not fall outside the limits,and the %CV must not be greater than the limit. If both meet the criteria, the asmbly has pasd the PVT.
