Standardization of Analytical Methodology and Procedures for Purity Assessment of Small Molecules in Drug Discovery

Abstract

Purity assessment of pharmaceutical compounds is a key part of ensuring data integrity for any biological assay carried out on such materials. Purity requirements and analytical procedures are different according to the drug discovery stage from chemical synthesis to compound selection for development. In the current climate of globalization and externalization, analytical laboratories should have the ability to deliver high quality levels of a service and to directly develop optimal methods and processes to be able to translate them into effective practices. For this, standardization in drug discovery laboratories working with external partners is of paramount importance to deliver consistent data and procedures, independent of the research site. This chapter reports the implementation and standardization of LC-MS methods and analytical procedures in Lilly research sites to deal with purity assessment and related substances determination in different stages of drug discovery.