Scopeia

Objective:

• • This test is provided to determine that tablets disintegrate within the prescribed time when placed in a liquid medium in the experimental conditions described below

Procedure:

• • Check the purified water level at the basin and sure it is at its mark.
  • Check the water colour and make sure of its cleanliness.
  • Turn the power of the Timer and the Heater ON.
  • Check the heater is setting on about 37 °C.
  • Fill the beaker with purified water to the level could cover the basket.
  • Put the beaker at its location on the basin and wait until the temperature of the water at the basin reach to 37 °C as indicated by the calibrated glass thermometer.
  • Place 1 dosage unit in each of the six tubes of the basket and, if prescribed add a disk.
  • Turn the timer ON and keep your eye on the tubes containers.
  • Unless otherwise specified, carry out the test for 20 minutes for capsules, 30 minutes for plain and uncoated tablets, and 60 minutes for coated tablets and pills.
  • At the end of the time limit specified in the monograph, lift the basket from the fluid, and observe the tablets: all of the tablets should have disintegrated completely
  • If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets.
  • The requirement is met if not less than 16 of the total of 18 tablets tested are disintegrated.

• • Disintegration is considered to be achieved when:
    • 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.
    • Any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disks, if used, is a soft mass having no palpably (noticeably and clearly) firm core.