Disintegration Test Limits for Tablets and Capsules

Disintegration test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions mentioned below.

Disintegration Limit as per BP

Uncoated tablets: Not more than 15 minutes

Film-coated tablets: Not more than 30 minutes

Coated tablets (other than film-coated tablets): Not more than 60 minutes

Gastro-resistant tablets: Not less than 120 minutes (acid stage)

Dispersible tablets: Not more than 3 minutes

Orodispersible tablets: Not more than 3 minutes

Oral Lyophilisates: Not more than 3 minutes

Hard capsules: Not more than 30 minutes

Soft capsules: Not more than 30 minutes

Disintegration Limit as per USP

Uncoated or Plain-coated tablets: As specified in the individual monograph

Delayed-Release tablets and Capsule: Not less than 60 minutes (acid stage)

Effervescent tablets: 5 min or as specified in the individual monograph

Dissolution Apparatus

The apparatus consists of a basket-rack assembly, a 1000-mL low-form beaker 138–160 mm in height and having an inside diameter of 97–115 mm for the immersion fluid, a thermostatic arrangement for heating the fluid 35°–39°, and a device for raising and lowering the basket in the immersion fluid at a constant frequency rate 29–32 cycles/min through a distance of NLT 53 mm and NMT 57 mm. The volume of the fluid in the vessel is such that at the highest point of the upward stroke, the wire mesh remains at least 15 mm below the surface of the fluid and descends to NLT 25 mm from the bottom of the vessel on the downward stroke. At no time should the top of the basket-rack assembly become submerged.

Use of Disks

The use of disks is permitted only where specified or allowed in the monograph. If specified in the individual monograph, each tube is provided with a cylindrical disk 9.35–9.65 mm thick and 20.55–20.85 mm in diameter.

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