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| Disintegration
If one or two
tablets/capsules fails (out of 6) to disintegrate completely, repeat the test
on additional 12 units: not fewer than 16 of the total 18 units tested shall
disintegrate completely*
*According to chapter
<701> of the USP, complete disintegration is defined as “...that state in
which any residue of the unit, except fragments of insoluble coating or capsule
shell, remaining on the screen of the test apparatus or adhering to the lower
surface of the disk, if used, is a soft mass having no palpably firm core.”
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Saturday, 25 February 2012
Disintegration Test - Pass/Fail Criteria
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