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Sep 1, 2015 · In 1948, the British Pharmacopoeia (BP) adopted a disintegration test for tablets based on observing the disintegration behavior in test tubes. 3 However, by that time, a specific disintegration testing apparatus had been used for 8 years by the laboratories of US Army Medical Department (Fig. 1), 4 and this apparatus formed the basis for the basket-rack assembly apparatus, first adopted by the United States Pharmacopoeia (USP) in 1950, 5 which is the apparatus currently used to perform the ...
The requirements of the test are met if not less than 16 of the 18 dosage units tested are disintegrated. References. 1. International pharmacopoeia; 5.3 Disintegration test for tablets and capsules; 10 th Edition, 2020. 2. British pharmacopoeia; 1. Disintegration of Tablets and Capsules, 2022. 3. United States Pharmacopeia Convention ...
Feb 20, 2019 · What is Disintegration: It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (environmental) for a group of tablets/capsules to disintegrate into particles.
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.
The disintegration test is an important quality control process that helps ensure that the proper manufacturing controls are in place. Agilent offers robust systems to accurately measure the disintegration of dosage forms into particles under standard conditions.
Aug 28, 2019 · Disintegration time is the key critical quality attribute for a tablet classed as an Orally Disintegrating Tablet (ODT). The currently accepted in vitro testing regimen for ODTs is the standard ...
May 6, 2020 · Updated: 9/18/2017] This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to ...
