The mechanical verification of pharmaceutical dissolution tester is to ensure the accuracy and reproducibility of the in vitro dissolution test data, and to ensure the consistency of the sample test results during the development and transfer of the dissolution method. According to the requirements of medicine consistency evaluation, after the dissolution apparatus is installed, moved and maintained, mechanical verification is required, usually once every 6 months.

For mechanical verification, it should meet the requirements of the Pharmacopoeia and the specified technical requirements. It is required to test the parameters including the horizontality of the dissolution tester, the verticality of the basket (paddle) axis, the verticality of the dissolution vessel, the coaxiality of the dissolution vessel and the basket (paddle) axis, the swing of the basket (paddle) axis, the swing of the basket, the depth of the basket (paddle), basket (paddle) shaft speed, dissolution vessel temperature, and vibration.

1. Speed (RPM)

2. Shaft swing

3. Basket swing

4. Shaft verticality

5. Verticality of dissolution vessel

6.Centrality of the dissolution vessel (upper and lower two positions)

7. Height of basket/paddle from vessel bottom

8. Levelness (dissolution tester, desktop)

9. Temperature in the water bath and the vessel

10. Vibration degree (acceleration, frequency, displacement, speed)

The dissolution apparatus is used for the dissolution test of tablets, capsules, pills, solid dosage form and various medicines, medicine quality control, and research and development. It is suitable for laboratories of scientific research institutes and pharmaceutical companies.