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Disintegration Time Procedure - SOP

The document outlines disintegration time procedures and requirements for different types of oral solid dosage forms according to various pharmacopeias, including uncoated tablets, sugar coated tablets, film coated tablets, enteric coated tablets, dispersible tablets, effervescent tablets, buccal tablets, soluble tablets, chewable tablets, gastro resistant capsules, hard gelatin capsules, soft gelatin capsules, and oral lyophilizates. It also provides calibration and timer requirements for the disintegration test apparatus.

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Prince Moni
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3K views

Disintegration Time Procedure - SOP

The document outlines disintegration time procedures and requirements for different types of oral solid dosage forms according to various pharmacopeias, including uncoated tablets, sugar coated tablets, film coated tablets, enteric coated tablets, dispersible tablets, effervescent tablets, buccal tablets, soluble tablets, chewable tablets, gastro resistant capsules, hard gelatin capsules, soft gelatin capsules, and oral lyophilizates. It also provides calibration and timer requirements for the disintegration test apparatus.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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

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