Calibration of the dissolution tester

Dissolution test is a quality control test used to evaluate different dosage forms such as pills, capsules, suppositories and pessaries etc. Each instrument should be calibrated to confirm desired performance according to the standards, Dissolution Test Apparatus Calibration Procedure. Types 1 and 2 are mentioned in the USP. There are two methods of calibrating the dissolution testing device, such as physical parameter and USP tablet standard. In physical calibration, check level setting, vibration, spindle speed (RPM), alignment, centering, hesitation, paddle/basket depth, timer and temperature, etc In the performance verification setting, dissolution calibration using USP Prednisone Calibration Tablets is used with distilled water.

Dissolution Tester Calibration Procedure:

Physical calibration:

Adjustment of the dilution level:

Be sure to level the dissolution test before calibrating with a bubble or spirit level. To adjust the level, turn the leveling knob provided at the bottom.

Calibration of the dissolution basket:

Dissolving Masons Calibration:

Dissolve Timer Calibration:

Set a timer for 30 minutes and turn on the instrument and stopwatch simultaneously, when the instrument is off, record the stopwatch reading and record observations. The acceptance limit of the timer must not deviate from ± 1 minute.

Dissolve Shaft Speed ​​Calibration:

Glue the basket or pallet to the instrument and set the 50 RPM. Touch the tachometer to each shaft, start the revolution and note the reading. Or manually count the number of revolutions per minute. Repeat the same process for 100 and 150 RPM alternately. Standard speed limit is NMT 4.0% of indicated rpm

Hesitation test (paddle stick/basket) Dissolution:

Make sure the paddle/basket shaft is clean and free of debris, connect it to the instrument and lower the instrument. Place the vibrometer on each box approximately 2 mm above the pallet/basket, so that the device does not come into contact with the pallet/basket. Run the machine at 50 rpm and measure the play of each shaft and basket in mm. Pallet/basket swing according to USP standard is 2.0 mm.

Calibration of the depth of the paddle/dissolution basket:

Alternately glue the pallet and the basket on each axis and lower the device. Place the caliper/depth gauge between the bottom of the tool and the bottom of the bowl. Measure the distance from the bottom edge of the paddle/basket to the innermost surface of the boat. The standard depth limit is 25.0 ± 2 mm.

Dissolution Temperature Calibration:

Set the temperature of the water bath to 37oC, place the vessels in a water bath and allow the dissolution medium to reach a temperature of 37oC. Using a calibrated thermometer, check that the temperature of the containers is within range. Repeat the same procedure for 35, 37 and 40oC. The standard temperature limit is ±0.50C.

Chemical calibration:

Dissolution calibration using prednisone tablets:

To taste: Prednisone tablets (disintegrating type) 50 mg.

Dissolution medium: 500ml purified water

Volume: 500ml

Temperature: 37°C±0.5°C

The rapidity: 50RPM

Duration: 30 minutes

USP Type I dissolution procedure: Set all the above parameters and perform the dissolution test for USP Type I using Prednisone tablets (disintegrating type). Calculate the prednisone content using the analytical UV/HPLC procedure at 242 nm. Acceptance criteria for USP Type I at 50 rpm is 45-75% release.

USP Type II dissolution procedure: Maintain the same conditions as described in USP Type I and repeat the procedure as USP Type I, but instead of spoons, use baskets. Acceptance criteria for USP Type I at 50 rpm is 35-65% release.

Calibrating the solution using salicylic acid tablets:

Calibration of dissolution test kits with salicylic acid tablets (non-disintegrating type) has been discontinued.

Why was the calibration of the Salicylic Acid Tablet Dissolution Tester stopped?

Salicylic acid pellets are unstable and tend to stick together and therefore do not meet analytical standards. Therefore, the salicylic acid tablets were removed from the calibration of the dissolution test device.

How often is the dissolution apparatus calibrated?

The physical calibration of the dissolution apparatus is performed every three months, while the chemical calibration is performed every six months.