Saturday, 25 February 2012

Disintegration Test - Pass/Fail Criteria

Disintegration Test - Pass/Fail Criteria


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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