Dissolution instrument performance calibration refers to checking and confirming the various performances of the dissolution instrument to ensure that it meets the requirements of national standards and relevant regulations. The following are general dissolution instrument performance calibration steps:
Clean the dissolution apparatus: Thoroughly clean and disinfect all parts of the dissolution apparatus to ensure that the instrument is clean and sterile.
Calibration temperature: Use a thermometer to calibrate the heating system of the dissolution instrument to ensure temperature accuracy.
Calibrate the rotation speed: Use a tachometer to calibrate the rotating part of the dissolution apparatus to ensure the accuracy of the rotation speed.
Calibrate the sampling volume: Use precision weighing instruments to calibrate the sampling volume to ensure the accuracy of the sampling volume.
Calibrate the sampling time: Use a timer to calibrate the sampling time to ensure the accuracy of the sampling time.
Calibrate pH value: Use a pH meter to measure and calibrate the pH value of the sample to ensure the accuracy of the pH value.
Calibrate the solution volume: Use a precision volumetric tube to calibrate the solution volume to ensure the accuracy of the solution volume.
When calibrating the performance of the dissolution apparatus, it is necessary to use some standard materials, such as standard thermometer, standard tachometer, standard pH buffer, etc., and record and check to ensure the accuracy and reliability of the calibration. Normally, dissolution apparatus performance calibration should be performed annually.
