Professional Documents
Culture Documents
Calibration of Disintegration Test Apparatus - Pharmaceutical Guidelines
Calibration of Disintegration Test Apparatus - Pharmaceutical Guidelines
-->
2. Record the frequency (of moving up and down) manually with respect to time.
4. Measure the frequency initially and after each fifteen minutes interval from the start, for 5 minutes each.
6. Divide the observed reading by five & note as the frequency of moving up & down per minute.
7. Perform the test for both the basket rack assembly positions (side A & side B) individually.
Acceptance criteria: The No. of cycles per minute should be within 29 to 32 throughout the period of operation.
3. Attach the basket rack assembly & start the constant frequency of moving up & down.
4. Insert the calibrated thermometer in one of the tubes of the basket rack assembly.
7. Record the temperature readings initially & after each 15 minutes interval up to 120 minutes from the start.
8. Perform the test for both the basket rack assembly positions (side A & side B) individually.
9. While performing the test, do not keep thermometer inside the basket rack assembly constantly, but insert 2 to 3 minutes prior to the measurement
to give stable reading.
Temperature (In °C)
Time (In Mins.)
Side A (Left hand side of the operator). Side B (Right hand side of the operator).
Initial
After 15
After 30
After 45
After 60
After 75
After 90
After 105
After 120
Acceptance criteria: The temperature should remain within 37 ± 1°C, throughout the operation.
2. Attach white paper firmly without kinks on the instrument, parallel to the path of the arm of basket rack assembly.
3. Select one point on the horizontal arm of the assembly & mark the same on the paper (pointed marker or pen can be used) when the assembly is
not moving & at its highest position.
4. Start the instrument by pressing START / STOP key & followed by pressing the respective timer key.
5. As soon as assembly reaches the lowest position, mark the same point again on the paper (while doing this activity take the time to decide the
https://www.pharmaguideline.com/2010/09/calibration-of-disintegration-test.html 1/2
6/7/22, 4:54 PM Calibration of Disintegration Test Apparatus : Pharmaceutical Guidelines
8. Perform the test initially, after 60 minutes from the start & after 120 minutes from the start.
9. Perform the test for both the basket rack assembly positions (side A & side B) individually.
Maintenance/ Repair
When the instrument does not comply with the requirements specified above; the instrument should be labeled as “Out of Calibration” and should be
repaired/ serviced. After repairing/ servicing, calibrate the instrument before use.
REFERENCE
United State Pharmacopeia
British Pharmacopoeia
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Copyright © 2008-2022
Pharmaceutical Guidelines
https://www.pharmaguideline.com/2010/09/calibration-of-disintegration-test.html 2/2