ABSTRACT

During the dissolution test, the hydrodynamic aspects of the fluid flow in the vessel have a major influence on the dissolution rate (1). Therefore, the working condition of the equipment is of critical importance. In this chapter, the qualification and calibration of the equipment referred to in the two USP General Chapters related to dissolution,< 711>Dissolution and < 724> Drug Release (2), will be discussed. Sources of error when performing dissolution

tests and using dissolution equipment will be examined in detail later in the chapter.