Disintegration Test

Hard gelatin capsules: IP uses disintegration test apparatus with 250 ml or 1L of specified disintegration medium maintained at 37 ± 2 °C and for specified time as per monograph. If 1–2 capsules fail, repeat for another 12 different units. 16 out of 18 capsules indicate that the test is affirmative.

BP uses disintegration test apparatus with water or specified liquid medium. Add a metal disc to prevent capsule from floating and operate for 30 min or as per monograph. If 1–2 fail, repeat for another 12 different units. Sixteen out of 18 indicate test is affirmative.

Soft gelatin capsules: IP uses disintegration apparatus with 250 ml or 1L of specified medium at 37 ± 2 °C and for specified time as per monograph. To test for disintegration time, one capsule is placed in each tube and the basket rack is positioned in a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 2 °C such that the sample remains 2.5 cm below the surface of liquid on their upward movement and not closer than 2.5 cm from the bottom of the beaker in their downward movement. Move the basket containing the capsules up and down through a distance of 5–6 cm at a frequency of 28–32 cycles per minute. If 1–2 fail, repeat for 12 different units. Sixteen out of 18 capsules indicate that the test is affirmative.

United States Pharmacopoeia (USP) procedure is similar to that of uncoated tablets. Place one dosage unit in each of the tubes of the basket with water or any other specified medium (depends on individual monograph) maintained at 37 ± 2 °C. Attach a removable wire cloth with a plain square weave of 1.8–2.2 mm of mesh aperture and a wire diameter of 0.60–0.655 mm to the surface of upper rack of the basket assembly. Observe the capsules for a time limit (specified in individual monograph), at the end of prescribed time, all of the capsules must have been disintegrated excluding the fragments from the capsule shell. No palpable material to remain on the mesh. If 1 or 2 capsules fail, the test should be repeated on additional of 12 capsules. Then, not lesser than 16 of the total 18 capsules tested should disintegrate completely.


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