Analytical Chemistry in a GMP Environment: A Practical GuideISBN: 978-0-471-31431-8
Hardcover
512 pages
May 2000
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The Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.).
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.
Laboratory Controls and Compliance (H. Avallone).
The USP, ICH, and Other Compendial Methods (J. Feldman).
Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).
Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).
Spectroscopy (P. Abauf & A. Melveger).
Chromatographic Principles (J. Miller).
Gas Chromatography (J. Miller & H. McNair).
Liquid Chromatography: Basic Overview (L. Polite).
HPLC Column Parameters (R. Hartwick).
Dissolution (R. Kirchhoefer & R. Peeters).
Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).
Some Principles of Quantitative Analysis (J. Miller).
Laboratory Data Systems (R. McDowall).
Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).
Appendices.
Index.