Analytical chemistry in a GMP environment :œba practical guide / 
edited by James M. Miller, Jonathan B. Crowther 
 - New York :  Wiley,  2000 
 - xxiv, 488 p. :  ill. ;  25 cm 
<br/><br/>Bibliography & index. 
<br/><br/>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 -- LiquidChromatography: 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 
<br/><br/><label>ISBN: </label>0471314315 (hbk.) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Drugs--Analysis--Quality control<br/>Pharmaceutical chemistry--Quality control
<br/><br/><label>Dewey Class. No.: </label>543  / A532  2000