Effervescent tablet disintegration time limit inspection method

Nov 11 , 2020

The disintegration time limit inspection method is used to check the disintegration of oral solid preparations under specified conditions.

Disintegration means that the oral solid preparations disintegrate and dissolve or break into granules under specified conditions. Except for insoluble coating materials or broken capsule shells, they should all pass through a screen. If there is a small amount that cannot pass through the screen, but has been softened or lightly floated and has no hard cores, it can be considered as compliance.

Inspection method: Hang the hanging basket on the support through the stainless steel shaft at the upper end, immerse it in a 1000ml beaker, and adjust the position of the hanging basket to lower it to a low point. When the screen is 25mm from the bottom of the beaker, the temperature inside the beaker is 37℃±1℃ Adjust the water level to make the screen 15mm below the water surface when the basket rises to the high point. The top of the basket cannot be immersed in the solution.

Unless otherwise specified, take 6 pieces of the test product and place them in the glass tubes of the above-mentioned hanging basket. Start the disintegration instrument for inspection. Each piece should be completely disintegrated within 15 minutes. If one tablet fails to disintegrate completely, another 6 tablets should be taken for retesting, all of which should meet the requirements.

Take 1 effervescent tablet and place it in a 250ml beaker (with 200ml of water at a temperature of 20℃±5℃), that is, many bubbles are released. When the gas around the tablet or fragments stops escaping, the tablet should dissolve or Dispersed in water, no aggregated particles remain. Except as otherwise specified, 6 tablets shall be inspected by the same method, and each tablet should disintegrate within 5 minutes. If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements.