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e constituent. Complete disintegration is defined as that state in which any residue of the unit, except fragments of insoluble coating or cap-sule shell, remaining on the screen of the test appa-ratus or adhering to the lower surface of the disk, if used, is a soft mass having no palp.
This test is provided to determine whether tablets, capsules, or granules USP 1-Aug-2019 disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions presented below.
A diagram illustrating a typical set up for the standard USP disintegration test for solid oral dosage forms that is also recommended for ODT disintegration testing. It shows how the...
This test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions presented below. For the purposes of this test, disintegration does not imply complete dissolution of the unit or even of its active constituent.
294 〈701〉 Disintegration / Physical Tests USP 35 Figure 1. Disintegration apparatus. (All dimensions are expressed in mm.) ate the apparatus, using water or the specified medium as Buccal Tablets—Apply the test for Uncoated Tablets. After the immersion fluid, maintained at 37±2°.
Determine the type of units under test from the labeling and from observation, and apply the appropriate procedure to 6 or more dosage units. For the purposes of this test, disintegration does not imply complete solution of the unit or even of its active constituent.
Dissolution testing as described in this chapter is a quality-con-made of a suitable, transparent plastic material having a specific trol tool to enable the performance of dietary supplements to begravity of between 1.18 and 1.20.
