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Fig. 2.5.1.-2. – Disintegration apparatus for test B Method Unless otherwise stated in the individual monograph, introduce one tablet or capsule into each of the three tubes and, if directed in the appropriate general monograph, add a disc to each tube. Suspend the assembly in the beaker containing the specified liquid and operate the apparatus for the specified time, Remove the
Feb 2, 2024 · Disintegration test apparatus is widely used in pharmaceuticals to identify the disintegration properties of various types of tablets and capsules. The DT apparatus decides whether or not tablets or capsules disintegrate within a recommended time once placed in a liquid medium.
Jun 3, 2023 · Disintegration is defined as that state in which no residue of the unit under test remains on the screen of the apparatus or, if a residue remains, it consists of fragments of disintegrated parts of tablets component parts such as insoluble coating of the tablets or of capsule shells, or of any melted fatty substance from the pessary or suppository or is a soft mass with no palpable core.
For the purposes of this test, disintegration doesplate is a woven stainless steel wire cloth, which not imply complete solution of the unit or even ofhas a plain square weave with 1.8- to 2.2-mm ap-its active constituent. Complete disintegration isertures and with a wire diameter of 0.57 to 0.66 defined as that state in which any residue of themm. The parts of the apparatus are assembled and
Disintegration stated in the individual monographs is required. USP 1-Aug-2019 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.
Disintegration of Tablets and Capsules, JP 6.09 Disintegration Test, and USP <701> Disintegration can be used as interchangeable in the ICH regions subject to the conditions detailed below. Testing conditions for specific dosage forms are outside the scope of the harmonization of this chapter. 2.1.1: The Disintegration Test is not considered to be interchangeable in the three regions for tablets and capsules larger than 18 millimeters (mm) long.
The International Pharmacopoeia - Eleventh Edition, 2022 5.3 Disintegration test for tablets and capsules. 1.18–1.20. Each disc is pierced by 7 holes, each 3.15 ± 0.1 mm in diameter, 1 in the centre and the other 6 spaced equally on a circle of radius 4.2 mm from the centre of the disc. The tubes are held vertically by 2 separate and superimposed rigid plastic
Mar 1, 2017 · The first official disintegration test was published in the Swiss pharmacopeia in 1934 . The method specified that a tablet has to be placed in a 100 mL conical container, then 50 mL of water at 37 ° C was added, and upon exposure of the tablet to water the container was shaken periodically. The disintegration time had to be 15 min or less.
Since its inception in the 1930s, disintegration testing has become an important quality control (QC) test in pharmaceutical industry, and disintegration test procedures for various dosage forms have been described by the different pharmacopoeias, with harmonization among them still not quite complete. However, because of the fact that complete disintegration does not necessarily imply complete dissolution, much more research has been focused on dissolution rather than on disintegration testing.
Using water or specified medium and a 60-min time limit. Disks are used if proscribed by the individual monograph. If they contain a crude drug, use the first fluid for disintegration.b If any residue remains, a successive 60-min test with the second fluidb for disintegration is carried out.
