This paper summarizes the provisions of USP toolkit 2.0 on the mechanical verification of dissolution instrument. USP toolkit specifies the good operation specifications for mechanical verification in the dissolution experiment of basket method and paddle method, so as to obtain reliable results in the dissolution experiment.
1. Environmental requirements
The test platform on which the dissolution instrument is placed must be stable and horizontal to avoid vibration. The levelness of the test platform shall be measured in two vertical directions, and the levelness of the test platform shall not exceed 1 degree.
2. Component requirements
The basket shaft and other components in the rotating structure need to be numbered and recorded, and should be kept in the same position during the experiment. The basket cup and other components used shall be in accordance with USP<711>, and the levelness of the dissolute cup support plate shall not exceed 0.5 degree when used.
The perpendicularity of the rotating shaft and the inner wall of the dissolution cup can be measured with a leveler, which shall not exceed 0.5 degrees from the standard.
The deviation between the measured value and the maximum value of 360.0mm in each rotation shall not exceed the minimum value. The compass in the figure below can also be used to replace the coaxiality measurement. When using this method, the distance from the rotating shaft to the inner wall of the dissolution cup needs to be measured. Four groups of vertical angles are measured, and the difference between the maximum deviation and the minimum deviation shall not exceed 2.0mm.
5. Swinging degree
A dial indicator can be used to measure the swing of the basket, and the measuring head of the dial indicator gently rests on the edge of the bottom of the basket. In a 360 degree measurement, the swing deviation shall not exceed 1.0mm. When measuring the swing degree of the propeller, the measuring head rests on the surface of the rotating shaft about 1cm along the upper edge of the propeller. In a 360 degree measurement, the swing degree shall not exceed 1.0mm.
The tachometer can be used to measure the speed. The speed of each rotating shaft needs to be measured. The speed needs to be set at 50rpm and 100RPM. The speed of each rotating shaft should be within ± 1rpm of the set value.
Place 500ml of water into each dissolution cup and set the temperature to 37 ℃. Use a calibrated thermometer to measure the temperature in each dissolution cup. The temperature deviation in each dissolution cup should not be less than 0.4 ℃, such as 36.7 ~ 37.1 ℃.
8. Verification cycle
The mechanical verification shall be conducted every 6 months. The dissolution instrument needs to be re verified after installation, relocation and maintenance.
The mechanical verification kit of Welch Materials can complete the mechanical verification of most models of dissolution instruments on the market. In addition, Welch Materials can also provide on-site verification services and overdue inspection services of verification tools.
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