STANDARD OPERATING PROCEDURE

USP DISSOLUTION APPPARATUS

Aim: This SOP describes the use and maintenance of a USP

dissolution test apparatus through proper installation, regular
monitoring and maintenance.
FUNCTION:

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
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.
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 set temperature.
4. Press the START key from the front panel to start the test after reaching
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 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 lower position and hence the test
cannot start.
8. Check that temperature is reached at set temperature, If instrument will
prompt an error screen stating the temperature has not yet reached and
hence the test cannot start.
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 wall of 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.