This fourth and last instalment in the “Separation Science in Drug Development” series provides an overview of modern practices of quality control in small-molecule drug development, including activities such as setting specifications, method validation and transfer, release and stability testing, and authoring chemistry, manufacturing, and controls (CMC) sections of regulatory filings.

An overview of modern practices of quality control in small-molecule drug development

Genotoxic impurities (GTIs) have gained considerable attention from health authorities as well as from the pharmaceutical industry in recent years.v

Material identification is a common need in many industries, most notably for pharmaceutical manufacturing where the United States Pharmacopeial Convention (USP) defines many identification tests.

A method is described that incorporates a mobile-phase gradient consistent with a HILIC separation mechanism and uses a mixed-mode column, which provides reversed-phase and cation-and anion-exchange properties, and charged aerosol detection.