What is the calibration parameter of disintegration test?
What is the calibration parameter of disintegration test?
Procedure for calibration of disintegration test apparatus (SAPO)
| S.NO. | PARAMETER | STANDARD |
|---|---|---|
| 1 | No. of Cycles/min. | Visually/Calibrated stop watch |
| 2 | Temperature | Calibrated Thermometer |
| 3 | Time | Calibrated Stopwatch |
| 4 | Aperture of wire mesh | Calibrated Vernier caliper |
How do you calibrate dissolution test apparatus?
CALIBRATION FOR DISINTEGRATING TYPE PREDNISONE TABLETS 50 MG
- Ensure that mains of instrument and supply are “ON”.
- Set the time program for 30 minutes, temperature 37° C + 0.5° C and for 50 RPM.
- Place 900 ml of deaerated water.
- After achieving the temperature place one tablet in each bowl and start the time program.
Which tablet is used for calibration of dissolution test apparatus as per USP?
Prednisone
Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.
What is the USP requirement for disintegration of uncoated tablets?
Uncoated tablets, except soluble tablets, dispersible tablets, effervescent tablets and tablets for use in the mouth comply with 5.3 Disintegration test for tablets and capsules. Operate the apparatus for 15 minutes, unless otherwise specified in the individual monograph, and examine the state of the tablets.
Why disintegration test is performed?
Why do we do it? Like dissolution testing, Disintegration is often a pharmacopoeial testing requirement for the vast majority of solid dosage forms. It provides critical safety data on drug bioavailability in the body without having to utilise in vivo methods.
Why dissolution is performed on 6 tablets?
Dissolution test is done to verify the release of drug in the solution from the tablet because of binders, granulation, mixing and the coating may affect the release of drug from tablets. Dissolution test is done using 6 units or dosage forms.
What is the criteria for disintegration test?
The test is met if all of the dosage units have disintegrated completely. If 1 or 2 dosage units fail to disintegrate, repeat the test on 12 additional dosage units. The test is met if not less than 16 of the total of 18 dosage units tested are disintegrated.
Why disintegration test is done?
The disintegration test is used to show how quickly the tablet breaks down into smaller particles, allowing for a greater surface area and availability of the drug when taken by a patient.
How to calibrate a disintegration test apparatus ( Sapo )?
To lay down a procedure for Calibration of Disintegration test apparatus (SAPO). This Standard Operating Procedure (SOP) is applicable to DT apparatus . Check the water level in the water bath. Fill the water in the beakers up to required mark. Operate the DT (Disintegration Test) machine as per SOP.
How often should vernier disintegration test apparatus be calibrated?
If the instrument is out of calibration then affix ‘UNDER MAINTENANCE’ tag and inform to maintenance department. The frequency for calibration of Disintegration Test apparatus shall be after every one month or after every maintenance work. Calibrated Vernier Caliper ID No.:
Which is the SOP for the disintegration test?
This Standard Operating Procedure (SOP) is applicable to DT apparatus . Check the water level in the water bath. Fill the water in the beakers up to required mark. Operate the DT (Disintegration Test) machine as per SOP. The following parameters shall be verified under the calibration of D T Apparatus.
What is the SOP for dissolution test apparatus?
This calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating dissolution test apparatus type 1 (basket apparatus) and type 2 (paddle apparatus) in accordance with USP requirements and cGMP (current good manufacturing practices).