ABSTRACT

Physical property characterization techniques such as determination of particle size, surface area, and density are covered in detail in chapter 3 dealing with the characterization of active pharmaceutical ingredients (APIs) and the raw materials for granulating. Rather than repeat the testing detail the information herein adds the characterization of the final granulations and will apply the data to verification of both the granulation design and its performance. Also the discussion of chemical characterization of granulations will be treated in the same way. Concerning performance the evaluation of dissolution, permeation, and in vivo-in vitro correlations will be covered under chapter 23 on properties and bioavailability. In this chapter we will deal with the remaining performance attributes in Table 1.