Operating Procedure for Dissolution Test (DT) Apparatus

1. Switch ‘ON” the power, instrument will initialize.
2. Press the RPM, TEMP, TIME, and OPTN keys from the front panel to set the parameters of the test.
3. Change protocol no. using Increment / Decrement keys.
4. Press the ENTER key to register the set parameter in the protocol, such 20 protocols can be prepared.

RPM Setting

1. Press the RPM key from the front panel. Set the RPM from 25 to 200 using the UP / DOWN / DIGIT SCROLL key as per requirement.
2. To start or stop the stirrer use F1 or F2 keys respectively.

Temperature Setting

1. Press the TEMP key from the front panel. Set the temperature from 30.0°C to 40.0°C by using UP / DOWN / DIGIT SCROLL key.
2. Switch heater ON/OFF BY using the function key F1/F2 Press ENTER key to register the change.
3. “TEMP ON” LED on the front panel will glow after switching on heater. The pump and the Heater ON LED on temperature Controller Unit ETC-11L will glow.

Sample Interval Setting

1. Press the TIME key from the front panel to display the screen for setting the Sample Interval Time.
2. Maximum 12 Samples Interval and the Sample Time can be set from 00 Min. to 23 Hrs, 59 Min. Set using UP / DOWN / DIGIT SCROLL key.
3. Press the ENTER key to register the value.
NOTE – If the SAMP. INTV. is kept to 00 Min. then that particular step will be skipped.
Related: SOP for Check Suitability of Dissolution Test Apparatus

Parameter setting from OPTN key

1. Set Bath Set Up, Sampler Set Up, Sampler Calibration, Print Set Up, Clock, Date, Wake-up Time, Circulating Pump, Temperature Control, and Power Fail delay, Cleaning Cycle etc. by using the OPTN key from the front panel.
2. Use Function key F1 (for NEXT) and F2 (for PREVIOUS) to scroll the parameters.
3. Press enter key to change the selected parameter.
4. Enter changes press enter key to register the changes made. NOTE – In case of filters to be immersed the filter will be at the top level of the media to avoid Hydrodynamic problem.
5. Use UP / DOWN keys and DIGIT SCROLL key to choose the test method as Paddle or Basket. Select method by using the UP / DOWN key. Press ENTER key to register the settings.
6. Press the scroll key to enable to select the filters to be immersed or remain outside the media pressing the ENTER key will register and OPTN screen will be displayed again. Use scroll UP or DOWN through the options using the Function keys F1 or F2 respectively.

Wakeup Time Setting

1. Press the F1 key to select the option for the Wakeup Time Setting.
2. Press the ENTER key to display the screen for the Wakeup time setting.
3. Set time and the date feature by using UP / DOWN & DIGIT SCROLL keys.
4. Keep sleep Mode ON using the Function key F1.
5. Keep main power supply on during wake-up mode, the backlight will be Off, it starts operating at set wakeup time and date.
Related: Tablet Dissolution Test in Different Stages (S1, S2 and S3)

Circulating Pump Setting

1. Press the F1 key to select the option for the Circulating Pump settings.
2. Press the ENTER key to display the screen for the Circulating Pump settings.
3. The pump can be set ON / OFF using the function key F1 or F2 respectively.
4. Press the ENTER key to register the value and the OPTN screen will be displayed again.
5. Scroll UP or DOWN through the options using the function keys F1 or F2 respectively.
6. Set the test parameters as required.
7. Insert the paddle/ Basket rod.
Related: Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped?

Procedure for USP apparatus I method (basket)

1. Check that set temperature is reached.
NOTE – When USP Apparatus I method (Basket) is used, place the test sample inside the basket and then insert the basket rod and lower the instrument by pressing Lift DOWN key provided on the Front Panel of TDT-08L.
2. Do not hold the basket on the mesh.
3. Hold the baskets at the ring of the open end and gently secure the basket is fully inserted on the basket holder.
4. Make sure that the basket is fully inserted on the basket holder.

Procedure for USP apparatus II method (paddle)

1. Insert the Paddle.
2. Lower the paddle by pressing Lift DOWN key provided on the Front Panel.
3. Drop the test Sample in test vessel after reaching the set temperature.
4. Press the START key from the front panel to start the test after reaching the set temperature. The instrument will now show the Run Time Screen.
5. Check the Run Time Screen for the Protocol no., The Step No., The Elapsed Sampling time for the particular Step, actual RPM of the stirrer, actual Bath Temperature and the temperature being measured by the external probe.
6. The RUN LED on the Front Panel will glow indicating the Instrument RUN Condition.
7. Check that paddle/basket are properly lowered, if instrument will prompt an error screen as lift is not at the lower position and hence the test cannot start.
8. Check that temperature is reached at a set temperature. If instrument will prompt an error screen stating the temperature has not yet reached and hence the test cannot start.

Resetting the Instrument

1. To RESET the instrument in Run condition, press the RESET Switch provided on the rear Right Hand Side. The Test will abort.

Halting/ Aborting Test

1. To halt the running test, press the STOP key once. The test will be Halted and the Halt Time will be displayed. The HALT LED on the Front Panel will start blinking.
2. Start the test by pressing F1, then the test will start from the point it has stopped and the Halt Time is not accounted. The instrument will display the Run Screen again.
3. Stop the test by pressing F2 key, then the test will be aborted and the instrument will show the idle screen.
Related: SOP for Operational Qualification of Dissolution Tester

Power Fail Condition

1. During test running time, if the Power fails then the Power Failure screen will be displayed when the power is resumed back.
2. The user can either start the test again or can stop the test by pressing the F1 or F2 key respectively.
3. If the F1 key is pressed, then the test will start from the point it has stopped and the instrument will display the Run Screen again.

Sample Withdraw Procedure

Withdraw sample from a zone midway between the surface of the dissolution medium and top of rotating basket/paddle, not less than 10 mm from the wall of the vessel.
Related: Dissolution Test and Apparatus

Dissolution Medium Preparation

Prepare the dissolution medium as per specified under monograph or procedure, filter through 0.45 mm filter paper under vacuum and stirring.
Note: Replace the water from the bath weekly or early if required.