溶出仪物理验证流程

温度探头
校验过的数显温度计
Recommend: Temperature within .38°C between each vessel 建议：每个溶出杯的温度差异小于0.4°
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数显水平 仪
Recommend: Vessel verticality no more than 0.5 degree 建议：溶出杯垂直度不超过0.5°。
7. Rotation Speed 轴转速
USP - Measure the rotation speed of all stirring element shafts using a tachometer. The rotation speed should be evaluated at both 50 rpm and 100 rpm. All measured speeds should be within ± 1 rpm of the set value.
9. Height Adjustment Gauge – To Record the Paddle Height Distance 25+/- 2 mm 深度测量装置-测量桨叶到溶出杯底部距离25+/- 2 mm
深度测 量装置
Height Adjustment Gauge – To Record the Basket Height Distance 25 +/-2 mm 深度测量装置-测量转篮到溶杯底部距离25 +/-2 mm
物理验证
Logan Instruments Date: June , 2016
一、物理验证工具包
定心轴 抖晃仪 支架 百分表
数显游 标卡尺 深度测 量仪
四分测 量仪
转速表
数显水 平仪
数显温 度计
定心盘
二、校验流程
1. Vessel Support Plate 溶出度仪水平度
USP —A spirit level may be used. Base plate inclination is not more than 0.5° in each of two orthogonal directions. Figure 1 shows that a reading closer to 0.0° can be achieved. Most base plate designs allow adjustment of levelness, if necessary, usually by rotating adjusting screws on the feet of the support and frame assembly. CFDA - 在溶出杯的水平面板上从两个垂直方向上测量，两次测量的数值均不得超出 0.5°。
测量的最大值与最小值之差不得超出1.0mm。
百分表 抖晃仪 支架
5.Basket Wobbling 篮摆动
USP - Use a dial test indicator to measure the wobble of each of the basket stirring elements with the dial test indicator probe tip at the bottom basket rim. Perform the total wobble measurement with the stirring element installed and slowly rotating through 360°. Total deflection of the probe tip must be less than 1.0 mm. CFDA- 在篮下缘处测量。篮轴以每分钟50转旋转时，连续测量15秒，每个篮测量的 最大值与最小值之差不得超出1.0mm。
数显水平 仪
4. Shaft Wobbling 轴摆动
USP - Measure the wobble for each paddle stirring element. Use a dial test indicator to measure the wobble for the paddle shaft at a point on the shaft about 1 cm above the paddle blade with the stirring element installed and slowly rotating through 360°. Total deflection of the probe tip must be less than 1.0 mm. CFDA:在篮（桨叶）上方约20mm处测量。篮（桨）轴以每分钟50转旋转时，连续测量15秒，每根篮（桨）轴
CFDA-将篮（桨）轴的转速设定在每分钟50（100）转，连续记录60秒，各篮（桨）轴的 转速均应在50（100）±4%转范围内。
校验过的转 数表
8.Shaft & Vessel Centering 溶出杯与篮（桨）轴同轴度
USP Guideline:
Alternatively, the centering can be measured using an inside divider to obtain a distance and measuring the distance with a vernier caliper or a micrometer . Where this alternative method is used, measure the distances from the shaft to the inner vessel wall at four locations equally spaced around the vessel and no more than 2 cm below the vessel flange . The difference between the largest and smallest readings is not greater than 2.0 mm.
百分表 抖晃仪 支架
6.Vessel Verticality 溶出杯垂直度
USP - Use a digital protractor to check the verticality of the vessels in the dissolution assembly. Measure the verticality for each vessel in two positions oriented at 90° around the vessel axis. The measurements are made on the vessel inner surface. The ideal reading obtained on a vertical surface is 90.0°. The deviation should be no more than 0.5° from 90.0° for this measurement. CFDA -沿溶出杯内壁（避免触及溶出杯底部圆弧部分）测量垂直度，再沿内壁旋转90°测 量，每个溶出杯两次测量的数值均不得超出90.0°±1.0°。
深度测 量装置
10.Temperature Control 溶出杯内温度
USP - Place vessels containing 500 mL of room temperature water in each position of the system. With the temperature control set to achieve 37°C in the vessels, measure the temperature of the water in each vessel using a calibrated thermometer. After equilibration, the medium temperature measured in all vessels should agree within a range of 0.4°C (e.g. 36.7° to 37.1°). CFDA-设定溶出度仪的水浴温度，取水900ml，置各溶出杯中，待温度恒定后，测量各 溶出杯内溶出介质的温度，均应为37℃±0.5℃。
数显水 平仪
2. Center定中心
• 将定心轴放到轴承里，定心盘卡到溶杯槽里，轴承尖端必须在定心盘中心圈 里，否则需要现场调整。
定心轴
定心盘
3. Shaft Verticality 篮（桨）轴垂直度
USP - Use a digital protractor to check the verticality of the stirring elements. Measure the verticality for each stirring element in two orthogonal. The ideal reading obtained on a vertical surface is 90.0°. The deviation should be no more than 0.5° from 90.0° for this measurement. CFDA -紧贴篮（桨）轴测量垂直度，再沿篮（桨）轴旋转90°测量，每根篮（桨）轴两 次测量的数值均不得超出90.0°±0.5°。
同心度可以内分规测得一个距离，或者使用游标卡尺或千分尺测量。在四个不同的位 置，测量转轴和溶出杯内壁之间的距离，等同于沿着溶出杯转动一周所测得的结果， 最大和最小读数之差不大于2.0mm. 转轴到溶出杯内壁之间的距离--90°四等分位置，最大和最小读数之差不大于2.0mm. B A 中心 度百 分表 游标 卡尺 四分 测量 仪