TY  - BOOK
AU  - Miller,James M.,|d1933-
AU  - Crowther,Janathan B
TI  - Analytical chemistry in a GMP environment :œba practical guide
SN  - 0471314315 (hbk.)
U1  - 543 
PY  - 2000///
CY  - New York
PB  - Wiley
KW  - Drugs
KW  - Analysis
KW  - Quality control
KW  - Pharmaceutical chemistry
N1  - 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
ER  -