Dissolution Testing

Dissolution Testing

Dissolution testing is an essential part of the pharmaceutical industry, providing critical in vitro drug release information that is used for quality control and drug development. In order to ensure the safety and efficacy of pharmaceutical products, laboratories regularly perform dissolution testing using Apparatus 1 (Basket) and Apparatus 2 (Paddle), in accordance with USP Chapter 711.

The process begins by selecting six different tablets for Stage S1 testing, determining the apparatus, medium, volume of medium, revolutions per minute (rpm), and time of dissolution. Each pill is then added to the dissolution tank, and the analysis is conducted in accordance with the predetermined parameters. At the end of the process, a small portion of the medium from each vessel is filtered and then tested for assay using either HLPC or UV/Vis methods.

If the conditions of Stage S1 are not met, an additional six tablets are evaluated during Stage S2. If the conditions of Stage S2 are not satisfied, an additional 12 tablets undergo Stage S3 testing. Each stage is further detailed in the separate monographs, which are organised according to the various tablet formulations.

Video 01: DISSOLUTION TESTING