Disintegration Test


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PowerPoint Presentation:

BY R RAMESH REDDY M.pharmacy 1styear-pharmaceutical analysis Disintegration Tester - Operation & Calibration 1

Disintegration Test:

Disintegration Test Disintegration is defined as that state in which no residue of the unit under test remains on the screen of the apparatus This test determines whether dosage forms such as tablets, capsules, pessaries and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions . 2

Disintegration Apparatus :

Disintegration Apparatus 3

For tablets and capsules:

For tablets and capsules The apparatus consists of a basket-rack assembly 1-litre beakers A thermostatic arrangement for heating the fluid A mechanical device for raising and lowering the basket in the immersion fluid at a constant frequency rate 4

For tablets and capsules:

For tablets and capsules 5


medium The assembly is suspended in the liquid medium in a suitable vessel, preferably a 1-litre beaker. The volume of liquid is such that the wire mesh at its highest point is at least 25 mm below the surface of the liquid, and at its lower point is at least 25 mm above the bottom of the beaker. At no time should the top of the basket-rack assembly become submerged. There is a thermostatic arrangement for heating the liquid and maintaining the temperature at 37º ± 2 6


Method Introduce one tablet or capsule into each tube Add a disc to each tube Suspend the assembly in the beaker containing the specified liquid and operate the apparatus for the specified time Remove the assembly from the liquid. The tablets or capsules pass the test if all of them have disintegrated If the tablets or capsules adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc 7

For enteric-coated tablets:

For enteric-coated tablets Method: Put one tablet into each tube, suspend the assembly in the beaker containing 0.1M hydrochloric acid and operate without the discs for 2 hours. Remove the assembly from the liquid. No tablet shows signs of cracks that would allow the escape of the contents or disintegration, apart from fragments of coating. Replace the liquid in the beaker with mixed phosphate buffer pH 6.8, add a disc to each tube and operate the apparatus for a further 60 minutes. The tablets pass the test if all six have disintegrated. 8

For pessaries and suppositories:

For pessaries and suppositories For Compressed Pessaries use with the hook-end downwards 9

PowerPoint Presentation:

A transparent sleeve of glass or plastic, 60 mm high with an internal diameter of 52 mm and an appropriate wall thickness. A metal device consisting of two stainless steel discs contains 39 holes, each 4 mm in diameter. The discs are separated by a distance of about 30mm. The metal device is attached to the outer sleeve by means of three equally spaced hooks. 10


method Place a pessary or suppository on the lower perforated disc of the metal device and then insert the device into the cylinder and attach this to the sleeves place each piece of apparatus in a vessel containing at least 4 liters of water at 36º to 37º and fitted with a slow stirrer and a means of holding the top of the apparatus 90mm below the surface of the water Alternatively, all three pieces of apparatus may be placed together in a vessel containing at least 12 liters of water. 11

PowerPoint Presentation:

Disintegration is considered to be complete when the pessary or suppository a) Is completely dissolved or b) Has dispersed into its component parts, which may remain on the surface (in the case of melted fatty substances), sink to the bottom (in case of insoluble powders) or dissolve (in case of soluble components) or may be distributed in one or more of these ways or c) Has become soft with appreciable change in shape, without necessarily separating into its components, and the mass has no solid core which cannot be pressed with a glass rod. 12

For Compressed Pessaries:

For Compressed Pessaries Adjust the level of the liquid until the perforations in the metal disc are just covered by a uniform layer of water. Place one compressed pessary on the upper perforated disc and cover the apparatus with a glass plate to ensure a humid atmosphere. Repeat the operation with a further two compressed pessaries. Disintegration is considered to be complete when a) there is no residue on the perforated plate or b) if a residue remains, it consists only of a soft mass having no solid core which cannot be pressed with a glass rod 13


CALIBRATION PROCEDURE Ensure the apparatus is properly connected to the power supply When the power is switched ON the TIMER and TEMP. shows digital value Set the temperature 37°C by using SET, TEMP Set the timer 15.00 by using  SET, TIME Start the temperature by push  the ENTER key 6   Fill the beaker of DT apparatus with  Purified water and adjust the temperature between 37 ± 1 O C Fix the beaker in its position and adjust the level of water. 14

PowerPoint Presentation:

Start the basket – rack assembly and  Timer  simultaneously Place the standardized calibrated thermometer  to record the actual temperature against the temperature displayed. Note the  temperature of water in the beaker and Oscillation per minute of the basket-rack assembly Switch OFF the apparatus and record the observations in the calibration record 15


ACCEPTANCE CRITERIA The temperature shall be between 37 ±  1 O C. The frequency of basket rack shall be between 29 to 32 per minute. FREQUENCY OF CALIBRATION Once in a month and after each maintenance job 16


INSTRUMENT CALIBRATION RECORD REF. SOP NO Revision No.: 00 Effective from Page No. : 1 of 1 Name of Instrument : Disintegration Test Apparatus Instrument Ser. No. : Make & Model: Calibration date: Calibration due on: 17

PowerPoint Presentation:

REMARKS: Satisfactory/ Not Satisfactory 18


reference IP 2007 vol-1 www.qualityassuranceprocedures.blogspot.in www.pharmaguideline.com www.pharmech.com 19

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