In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e. to assess batch-to-batch consistency of solid oral dosage forms such as tablets and drug development, i.e. to predict in vivo drug release profiles. is necessary. Both Apparatus 1 (Basket) and Apparatus 2 (Paddle) for dissolution testing EUROLAB It is used by.
In Step S 1 of the dissolution test, 6 tables are tested. The following parameters are chosen: apparatus, medium, media volume, rpm and dissolution time.
Each tablet is placed in the dissolution vessel and analysis continues at the specified time according to the selected parameters. Finally, a sample of the medium is taken from each container and filtered.
The filtrate is tested for Experiment using the appropriate method. The most common methods are HLPC or UV / Vis. If the requirements for Stage S 1 are not met, an additional 6 tablets are tested as Stage S 2.
If the requirements for Step S 2 are not met, an additional 12 tablets will be tested as Step S 3.
The specifications of the relevant stage are specified in a separate monograph according to the type of tablet (individual release, extended release, delayed release, etc.).
EUROLAB, with its highly expert team and internationally accredited laboratories, Drug Dissolution Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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