Disintegration Time procedure – SOP

 Uncoated Tablet 15 min as per BP & 30 min as per USP

 Sugar Coated Tablet 60 min as per BP
 Film Coated Tablet 30 min as per BP
 Plain Coated Tablets DT in specific medium for 30 min as per USP
 Enteric Coated Tablets DT in  simulated gastric fluid (0.1 M HCl) for 1 hr and
then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per
USP.
 Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
 Effervescent Tablets 1 tablet in 200 mL water  for 5 min ( 15- 25º C )
as per BP
 Buccal Tablets 4 hrs as per USP.
 Soluble Tablets 3 min ( 15- 25º C ) as per BP.
 Chewable Tablets are not require to comply with test.
 Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl  and phosphate
buffer pH 6.8 for further  60 min as per BP.
 Hard gelatin capsule DT 30 min as per BP & USP.
 Soft gelatin capsule DT 30 min as per BP .
 Oral lyophilizates DT disintegrate within 3 min Using a beaker containing 200 
mL of water at 15 °C–25 °C. Six units tested, 1 at a time as per BP & phEur.

Calibration:

 Cycles of shaft holding the tube basket (1 min) = Limit 29-32 Cycles Per Minutes
 Distance covered by the shaft = Limit 55 ± 2 mm
 Beaker Temperature (60 min) = Limit 37º ± 2º C
 Sieve integrity check (Aperture opening) = Limit 1.8 – 2.2 mm
Timer :

 Time in 3 min = Limit 3 min ± 3 sec

  Time in 15 min = Limit 15 min ± 18 sec
 Time in 30 min = Limit 30 min ± 36 sec
 Time in 60 min = Limit 60 min ± 1 min 12 sec
 Time in 120 min = Limit 120 min ± 2 min 24 sec
 Start the instrument and record the time with calibrated stop watch