Improved Pharma COO Pamela Smith is co-author of a chapter in the latest edition of Specification of Drug Substances and Products: Development and Validation of Analytical Methods. The chapter, Solid-State Characterization – Method Development and Validation, focuses on the key issues that must be addressed when developing solid-state methods. Method development and validation for pharmaceuticals is described in detail in several guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the United States Pharmacopeia. However, these guidelines are primarily focused on chromatography and not solid-state techniques. This chapter describes method development and validation for solid-state analytical techniques and reviews some of the important requirements for proper sample preparation and testing. Good sample homogeneity is a requirement that may be difficult to achieve for many solid materials, but it is a critical parameter in obtaining consistent results for solid-state method development and validation. Examples are shown for solid-state method development processes, which illustrate some of the unique problems associated with solid samples.
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