Analytical method validation and instrument performance verification
By: edited by Chung Chow Chan ... [et al.].
Contributors: Chan, Chung Chow.
Publisher: Wiley-Interscience
Published: 2004
Place of publication: Hoboken, N.J
Language: eng
Number of pages: 303
Subjects: Drugs -- Analysis -- Methodology -- Evaluation.; Laboratories -- Equipment and supplies -- Evaluation.; Laboratories -- Instruments -- Evaluation.; Chemistry, Pharmaceutical -- instrumentation.; Chemistry, Pharmaceutical -- methods.; Clinical Laboratory Techniques -- standards.; Technology, Pharmaceutical -- methods.
Notes: Includes bibliographical references and index.
Table of contents: title: Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen; title: Potency method validation / Chung Chow Chan; title: Method validation for HPLC analysis of related substances in pharmaceutical drug products / Y.C. Lee; title: Dissolution method validation / Chung Chow Chan ... [et al.].; title: Development and validation of automated methods / Chantal Incledon and Herman Lam; title: Analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang; title: Validation study of JP heavy metal limit test / Yoshiki Nishiyama; title: Bioanalytical method validation / Fabio Garofolo; title: Procurement, qualification, and calibration of laboratory instruments: an overview / Herman Lam; title: Performance verification of UV-Vis spectrophotometers / Herman Lam; title: Performance verification of HPLC / Herman Lam; title: Operational qualification of a capillary electrophoresis instrument / Nicole E. Baryla; title: LC-MS instrument calibration / Fabio Garofolo; title: Karl Fisher apparatus and its performance verification / Rick Jairam, Robert Metcalfe, and Yu-Hong Tse; title: The pH meter and its performance verification / Yu-Hong Tse, Rick Jairam, and Robert Metcalfe; title: Qualification of environmental chambers / Gilman Wong and Herman Lam; title: Equipment qualification and computer system valication / Ludwig Huber; title: Validation of Excel spreadsheet / Heiko Brunner.