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Calibration of Dissolution Testing Apparatus


Learn the calibration of Dissolution Test Apparatus using Disintegrating Prednisone tablets.

RPM  CALIBRATION

1.  Enter the required RPM value in the range of 30 to 200.
2.  Press ENTER key to terminate. The SET RPM key LED will now be put off.  If the RPM value is not in the above-mentioned range error message Er is displayed on the RPM display.
3.  If the error message is displayed then go back to resetting. If the error message "Er" is displayed on the RPM display and the ENTER key is pressed then the last correctly set value of RPM for that step will be accepted and the SET RPM LED will be put off.
4.  Suppose RPM value 100 is to be entered. First press the SET-RPM key. The SET-RPM key LED will be illuminated., Next press number 1 key once following by 0 key twice, Then press ENTER key. The SET-RPM key LED will go OFF, Then the RPM DISPLAY will show 100.
5.  Record the RPM manually & enter in the calibration log.

TEMPERATURE CALIBRATION

1.  Press the SET key. The SET TEMP key LED will be illuminated TEMP.
2.  Enter the required temperature value in the range of 30.0 °C to 100 °C.
3.  Press ENTER key to terminate. The SET TEMP key LED will now be put off.  If the Temp. is not in the  above-mentioned  range then the error message Er is displayed on the TEMP display. If the error message is displayed then go back to resetting.
4.  If the error message "Er" is displayed on the TEMP display and the ENTER key is pressed then the last correctly set value  of TEMP for that step will be accepted and the  SET TEMP LED will be put off.
5.  Set the temp. 35°c, 37° & 40°c and check the temperature of bowl with the thermometer & record the data in Calibration log.
6.  To view the set temperature presses the SET TEMP key again. Then the TEMP DISPLAY will show set temp in °C.
7.  If the calibration is not found within the specified limits immediately inform to QC head.  
Affix the calibration label on the instrument.

CALIBRATION FOR DISINTEGRATING TYPE PREDNISONE TABLETS 50 MG

1.  Ensure that mains of instrument and supply is “ON”.     
2.  Set the time program for 30 minutes, temperature 370 C + 0.5 ° C and for 50 RPM.      
Fit the paddle apparatus.          
3.  Place 900 ml of deaerated water.
4.  After achieving the temperature place one tablet  in each bowl and start the time program.
5.  After the completion of time program withdraw the sample solution from each bowl and filter through the whatman filter no. 41 in individual tubes. Discard first 50 ml filtrate, take 5 ml of filtrate and dilute with water to 25 ml and take the absorbance at 242 nm against the water.
6.  Prepare the standard solution by dissolving the 25 mg of prednisone to 50 ml of water, further dilute it 5 ml to 50 ml with the water , further dilute 5  ml to 25 ml with water and take the absorbance at 242 nm against the water.(If the standard is not dissolves first add not more than 2.5 ml of alcohol)
7.  Calculate the content of prednisone. Also carry out above procedure for 100 rpm. Enter the data in the calibration log.
8.  Also carry out above procedure by changing the basket apparatus for 100 RPM and enter the data in calibration log.
•  If the calibration is not found within the specified limits immediately inform to QC  head.
•  Affix the calibration label on the instrument.     
•  In case of noticing any malfunctioning of instrument, inform the maintenance dept. and Head of the dept

Checking of  physical parameters for the apparatus :

Basket

Make Identity of the each basket which is in use and make the inventory. Check the physical parameters for the each basket like appearance, opening, height, total height of basket, ID of basket, external diameter of basket, external diameter of ring, vent hole diameter, height of coupling disk. All parameters should fall within the limit as given in the calibration log.

Paddle

Make Identity of the each paddle which is in use and make the inventory. Check the physical parameters for the each paddle like appearance, height, shaft diameter, blade upperchord, lower chord, height, radius (disk), thickness, and distance from bottom, distance shaft axis and vertical axis of vessel. All parameters should be fall within the limit as given in the calibration log.

Checking of wobbling, Rotations, and distance parameters for the apparatus

Wobbling

•  Fix the paddle/basket apparatus to the instrument, lower the apparatus.
•  Fix the wobbling meter on the top of the bowl.
•  The needle of wobbling meter should touch to the surface of the apparatus.
•  Measure the wobbling on the meter.

Rotation

•  Fix the paddle/ basket apparatus to the instrument.
•  Set the RPM 50/100.
•  The needle of tecometer should touch to the surface of the apparatus.
•  Press the “start” key of tecometer to start
•  Fix the tecometer with apparatus.
•  Start the rotation.
•  The tecometer will show you result on display.

Distance from the apparatus

•  Fix the paddle/basket apparatus to the instrument, lower the apparatus.
•  Insert the varnier calipers between the bottom of the apparatus and the bottom of the bowl.
•  Measure the reading on the display.


TEMP./RPM CALIBRATION

Model No.                   :  
Make                   : 
Instrument Code No.    :
Thermometer code #      :

Sr  #
Type of calibration
Set value
Observed value
Limits
1
2
3
4
5
6
1
35° C
34.5 - 35.5°C
Temp 0C
37° C
36.5 - 37.5°C
40° C
39.5 - 40.5°C
2
50
48-52
RPM
100
96-104
150
144-156
Calibration Status         :  Satisfactory / Not Satisfactory
Next Calibration Due    :
Calibrated By   :                                                                             Checked By     : 
Date                  :                                                                            Date                :


CALIBRATION LOG (FOR DISINTERATING TYPE)

Model                          :  
Make                   : 
Instrument Code No.    :
Lot no of  tablet  :
Std. Preparation : (Code of WRS___________)
Transferred __________ mg (25 mg ) to 50 ml volumetric flask, dissolved and diluted to 50 ml with water. 
Diluted _________( 5 ml ) to 50 ml with water and mix. Diluted _________( 5 ml ) to 25 ml with water and mix.

Weight of tablet
Dissolution time
Diluted to
(5 ml to 50 ml)
Diluted to
(5 ml to 25 ml)
UV reading at 242 nm)
Remark
From
To
       1.
       2.
       3.
       4.
       5.
       6.

Sr. No.
Set apparatus
Observed
 value
50 rpm
100 rpm
Limits
1.
Apparatus I
Min.:
Max.:
Mean.:
2.
Apparatus II
Min.:
Max.:
Mean.:

Calibration Status         :  Satisfactory / Not Satisfactory
Next Calibration Due   :
Calibrated By   :                                                                                   Checked By     :
Date               :                                                                                     Date                : 

PHYSICAL PARAMETER (PADDLE)

Model No.                   :  
    Make              : 
Instrument Code No.    :

Sr.
No.
Parameter
Specifications
Observations
Remark
1
2
3
4
5
6
mean
1.
Shaft diameter 
9.4 - 10.1 mm
2.
Blade upper chord
74.5 ± 0.5 mm
3.
Lower chord
42.0 + 1.0 mm
4.
Paddle Height
19.0 + 0.5 mm
5.
Thickness
4.0 + 1.0 mm
6.
Distance from bottom
25 +2 mm.
Calibration Status        :  Satisfactory / Not Satisfactory
Next Calibration Due    :
Calibrated By   :                                                                    Checked By     :
Date                 :                                                                    Date                 : 

PHYSICAL PARAMETER (BASKET)

Model No.                   :  
Make                   : 
Instrument Code No.    :

Sr.
No.
Parameter
Specifications
Observations
Remark
1
2
3
4
5
6
mean
1.
Total height of basket
37.0 +3.0 mm
2.
Height of screen
27.0 ± 1.0 mm
3.
ID of screen
20.2 + 1.0 mm
4.
External diameter screen
22.2 + 1.0 mm
5.
External diameter of ring
25.0 + 0.02 mm
6.
Hole diameter
2.0 +0.5 mm
7.
Height of coupling disk
5.1 + 0.5 mm
8.
Distance from bottom
25 +2 mm.
Calibration Status         :  Satisfactory / Not Satisfactory
Next Calibration Due    :
Calibrated By   :                                                                                   Checked By     :
Date                 :                                                                                   Date                 :

CHECKING OF WOBBLING, ROTATION AND DISTANCE

Model
Code No.

Test unit
Paddle wobble
Basket wobble
Paddle rotation
D1 mm
D2 mm

USP standards
(2.0 mm)
(2.0 mm)
(4 % of set rpm)
(25.0+ 2.0 mm)
(25.0+ 2.0 mm)

50 RPM
100 RPM

1.        

2.        

3.        

4.        

5.        

6.        

D1
Distance between the bottom edges of the blade to the lowest inner surface of the vessel.

D2
Distance between the bottom edges of the basket to the lowest inner surface of the vessel.


Calibration Status         :  Satisfactory / Not Satisfactory
Next Calibration Due    :
Calibrated By   :                                                                       Checked By     :
Date                 :                                                                       Date                 : 



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