The Laboratory Analyst's Role in the Drug Development Process -- Laboratory Controls and Compliance -- The USP, ICH, and Other Compendial Methods -- Statistics in the Pharmaceutical Analysis Laboratory -- Basic Analytical Operations and Solution Chemistry -- Spectroscopy -- Chromatographic Principles -- Gas Chromatography -- Liquid Chromatography: Basic Overview -- HPLC Column Parameters -- Dissolution -- Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products -- Some Principles of Quantitative Analysis -- Laboratory Data Systems -- Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods -- App. I List of Symbols and Acronyms -- App. II Glossary of Terms used in ICH Documents -- App. III Universal Tests, Dosage-Form-Specific Tests, and Acceptance Criteria -- App. IV USP Chromatographic Phases

1. Drugs -- Analysis -- Quality control
2. Pharmaceutical chemistry -- Quality control