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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. The Agilent 100 automated disintegration apparatus is a fully programmable ...
Oct 1, 2023 · The standard disintegration test (SDT) is clearly defined in Pharmacopoeia with limited information on the disintegration process. Therefore, it seems to be worthy and urgent to quantify the disintegration phenomenon and try to reveal the underlying mechanism and tablet microstructure of the disintegration based on the use of advanced technologies and software methods.
May 6, 2020 · Q4B Annex 5: Disintegration Test General Chapter. Updated: 9/18/2017] This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert ...
Jul 24, 2010 · In QbD, a disintegration test might be justified to substitute a single-point dissolution test if the drug particle size ensures a sufficient rate of dissolution and disintegration is the rate-limiting step for drug release . However, to be able to use the disintegration test as a performance test in QbD, its suitability as a performance test must be investigated.
Oct 30, 2023 · A disintegration test is a pharmaceutical quality control test that assesses the ability of a solid dosage form, such as a tablet or capsule, to break down or disintegrate into smaller particles when exposed to a liquid environment. The test helps ensure that the medication can rapidly disintegrate in the digestive system, making the active ...
The test is usually performed on tablets, capsules, and enteric-coated tablets, and it provides critical safety data on the bioavailability of drugs in vivo without the use of in vivo methods. Therefore, disintegration testing is very important for oral formulations. CD Formulation can provide analytical services for a variety of dosage forms.
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.
