Practical Guidelines for the Characterization and Quality Control of Nanoparticles in the Pharmaceutical Industry

Abstract

Nanomaterials are used in a wide range of applications bringing completely new properties to a material or considerable improving pristine material property. In the medical domain where they are named nanomedicines, their usefulness was found to resolve drug delivery challenges and to improve performances of imaging-based diagnostic methods. Some carry activity on their own giving birth to new types of medicines. Whatever the application of the nanomaterial is for, a quality assessment is needed to ensure the repeatability and efficiency of industrial processes and in turn activity and safety of the product. This chapter was aimed to discuss the characterization of physicochemical parameters that can be used to define a nanomaterial. It gives basis in metrology and explains how it can be used to develop validated procedures for the characterization of the main physicochemical parameters that define NMs including their transfer to be used in many laboratories. Examples discussed in the chapter include the measurement of the size of NMs, the evaluation of the size distribution and of the zeta potential. The development of validated procedures for the characterization of NM is in its infant ages facing challenges that are discussed in this chapter.

llmenite and Biomass Composite Nanomaterials - A Review

“…To correctly evaluate the nanocomposite's structural, morphological, and functional features, thorough characterization procedures are needed. Reliable and repeatable applications depend on the synthesized material's consistent quality and performance, which is ensured by strict quality control procedures [147].…”