API's, powders, granules

The dosage form for a pharmaceutical contains the active pharmaceutical ingredient (API), which is the biologically active drug itself, and excipients, which are the substances of the tablet, or the liquid the API is suspended in. Many powders, because of their small size, irregular shape or surface characteristics, are cohesive and do not flow well. Granules produced from such a cohesive powder will be larger and will have better flow properties. The granulation process (wet or dry) combines one or more powder particles and forms a granule (large particle or grain) that will allow tableting to be within required limits.

Quality control tests

The following tests are routinely performed for powders and granulates with SOTAX instruments: