Stage 4 Harmonization a701n 1 Official May 1, 2020 a701n DISINTEGRATION Change to read: This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese ...
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...Stage harmonization an official may disintegration change to read this general chapter is harmonized with the corresponding texts of european pharmacopoeia and or japanese these pharmacopeias are therefore interchangeable methods be used for demonstration compliance instead present have undertaken not make any unilateral portions text that national usp part marked symbols specify fact test provided determine whether tablets capsules granules disintegrate within prescribed aug time when placed in a liquid medium at experimental conditions presented below limits on stated individual monographs required type units under from labeling observation apply appropriate procedure more dosage purposes does imply complete solution unit even its active constituent defined as state which residue except fragments insoluble coating capsule shell remaining screen apparatus adhering lower surface disk if soft mass having no palpably firm core consists basket rack assembly ml low form beaker mm height in...