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Tianjin Jiaxinhai Machinery Equipment Co., Ltd

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Mechanical verification of dissolution tester
Date: 2025-09-29Read: 0


The mechanical verification of the dissolution apparatus should place the tested component in the normal dissolution test position and have relevant technical personnel use appropriate measuring tools to measure various mechanical parameters. Single measuring tools such as inclinometers, coaxiality measuring tools, pendulums, depth gauges, tachometers, and thermometers can be used, or modular integrated measuring tools can be used. Regardless of the type of measuring tool, it should be used within the qualified calibration period and able to trace the measurement value.

溶出度仪的机械验证

Using appropriate measuring equipment, perform mechanical validation of the dissolution apparatus according to the following steps. (1) Level of dissolution apparatusdegree  Measure from two vertical directions on the horizontal panel of the dissolution cup, and the inclination should not exceedpass0.5°. (2) The basket (paddle) axis is verticaldegree Measure the verticality closely against the basket (paddle) axis, and then rotate along the basket (paddle) axisturn90°Measurement, each basket (propeller) shaft must not exceed the measurement value twicepass0.5°. (3) Vertical dissolution cupdegree Measure the verticality along the inner wall of the dissolution cup (avoiding touching the bottom arc of the dissolution cup), and then rotate along the inner wallturn90°Measurement, each dissolution cup must not exceed the measurement value twicepass1.0°. (4) Coaxial dissolution cup and basket (paddle) axisdegree Basket method: A measuring point is located above the basket, at a distance from the basketfate2mmThe other measurement point is located above the basket, far from the basketfate60mm. Paddle method: A measurement point is located above the blade, at a distance from the bladefate2mmThe other measurement point is located above the blade, at a distance from the bladefate80mm. At the above two measurement points, the deviation between the axis of each dissolution cup and the axis of the basket (paddle) shall not exceedpass1.0mm. The basket shaft, paddle, and dissolution cup that have passed the verification of perpendicularity and coaxiality should be numbered and marked at the position where the upper edge of the dissolution cup is connected to the fixing device. When conducting dissolution tests, each basket shaft, paddle, and dissolution cup should be placed in the original validated position, while maintaining the relative position of each dissolution cup to the fixture unchanged. To meet the coaxiality requirements, the verticality of the dissolution cup should be re verified after adjusting its position. 

溶出度仪的机械验证

 (5) Swing of basket (paddle) shaftmove On the basket (paddle)square20mmMeasure at the location. Basket (paddle) shaft per minutebell50Continuous measurement during rotationquantity15Within seconds, the swing of each basket (paddle) shaft must not exceedpass1.0mm(6) Basket swingmove Measure at the bottom edge of the basket. Basket axis per minutebell50Continuous measurement during rotationquantity15Seconds, the swing of each basket must not exceedpass1.0mm. The baskets that have passed the swing verification should be numbered. When conducting the dissolution test, each basket should be placed in the original verified position, keeping its relative position with the fixed device unchanged. (7) The depth of the basket (paddle)degree Measure the distance between the lower edge of the basket (paddle) in each dissolution cup and the bottom of the dissolution cupfor25mm±2mm. (8) Rotation of basket (paddle) shaftquick Set the speed of the basket (paddle) shaft to every minutebell50(100)Turn around. Continuous recordingrecord60In seconds, the rotational speed of each basket (propeller) shaft should beIn50(100)±4%Within the scope of transfer. (9) Dissolve the temperature in the cupdegree Set the water bath temperature of the dissolution apparatus and takewater900mlInject into each dissolution cup, wait for the temperature to remain constant, and measure the temperature of the dissolution medium in each dissolution cupfor37℃±0.5℃. (10) Vibrationmove When the dissolution apparatus is running, the entire device should remain stable, and no part of the dissolution apparatus (including the environment) should produce significant movement or vibration(≤0.1mil).