Calibration of Dissolution Test Apparatus

PROCEDURE :
OPERATION:
Connect the Disintegration Test Apparatus to main power supply.
Switch on the MAINS.
Green coloured LED and display will glow.
Keep 1 litre  glass beaker on the hot plate of apparatus.
Fill the medium (generally distilled or purified water if not specified in monograph) in the beaker such that at the highest point of upward stroke the wire mesh of the basket remains at least 25 mm below the surface of the medium and during the downward stroke lower point is at least 25mm above the bottom of the beaker.
Maintain appropriate temperature (as per monograph) with HEAT control knob.
Bring the temperature of the media at 37°C (±2°C ), or as specified in monograph.
Place the tablet or capsules in each of six tubes of basket assembly and add disc to each tube.
Do not put disc if not allowed in monograph.
To set the required Time press ’SET’ switch.
Orange coloured LED will glow.
Adjust the set time by ‘UP’ and ‘DOWN’ switches.
Press START switch.
Indication will switch over from 'Set Time' to 'Actual Time'.
Start LED will glow & timer will start counting the Time.
Lift the basket from the medium and observe the tablets.
The tablets or capsules pass the test if all of them have disintegrated.
If 1 or 2 tablets or capsules fail to disintegrate, repeat the test on 12 additional  tablet or capsules not less than 16 of the total of 18  tablet or capsules tested disintegrate.
If the  tablet or capsules adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc.
The preparation complies with the test if all the  tablet or capsules in the repeat test disintegrate.
CALIBRATION:
NUMBER OF CYCLES PER MINUTES:
Record the frequency of moving UP and DOWN of the basket assembly in a time mentioned in below table.
Record the frequency( twice) of moving UP and DOWN of basket  assembly manually with respect to time in Calibration format.
Do not stop instrument in between the operation.
Sr. No. Time (Minutes) Number of  Cycles observed Mean of Left and Right side Number of  Cycles Per Minute = Mean    Time Left side Right side 1 5 2 10
Acceptance criteria :
The number of cycle per minute is within 28 to 32 through out the period of operation.
TEMPERATURE VERIFICATION:
Fill the beaker with distilled water.
Attach basket assembly and start the instrument.
Insert the calibrated thermometer in one of the tube of basket assembly.
Wait till temperature reaches between 350C to 390C.
Start recording the reading.
Record temperature reading after 05 minutes interval up to 60 minutes   from the start.
Perform the test for both the basket assembly position individually.
While performing the test, do not keep thermometer inside the basket  assembly constantly.
Insert the thermometer between 2 to 3 minutes prior to the measurement
of temperature to give stable reading.
Sr. No. Time (Min.) Temperature 0C Left hand side Right hand side 1 5 2 10 3 15 4 30 5 45 6 60
Acceptance criteria :
The temperatures remain 37+20C through out the operation.