Abstract
Characterization of substances and formulations with respect to purity and stability is a major analytical chemical task during product development in the pharmaceutical industry. The importance of separation methods, especially liquid chromatography, is shown with some examples from work with omeprazole. The role of mass spectrometry (MS) for structure elucidation is emphasized. Dissolution testing comprises a large number of samples and adaptation to standardized procedures is important. Work is exemplified with dissolution testing of felodipine. Automation and robots with multivariate calibration are necessary approaches. Macromolecular characterization is exemplified from the fields of biomolecules and macromolecular excipients. Separation methods and MS are important tools. New challenges in the area of process analytical chemistry are discussed and chemometrics will play an important role. In all fields method validation is stressed, but should not require more power than necessary in a specification.
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