Analytical chemistry in a GMP environment :œba practical guide / edited by James M. Miller, Jonathan B. Crowther

Contributor(s): Miller, James M.,|d1933- | Crowther, Janathan BCall number: 543 A532 2000 Material type: BookBookPublisher: New York : Wiley, 2000Description: xxiv, 488 p. : ill. ; 25 cmISBN: 0471314315 (hbk.)Subject(s): Drugs -- Analysis -- Quality control | Pharmaceutical chemistry -- Quality controlDDC classification: 543 A532 2000
Contents:
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
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General Books General Books สำนักวิทยบริการ (Center)
ชั้น 7 หนังสือทั่วไปภาษาอังกฤษ 000-900 		543 A532 2000 (Browse shelf(Opens below)) 1 Available 2000067210

Bibliography & index.

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

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