Analytical method validation and instrument performance verification [electronic resource] /
edited by Chung Chow Chan ... [et al.].
- Hoboken, N.J. : John Wiley, c2004.
- x, 303 p. : ill. ; 24 cm.
Includes bibliographical references and index.
Overview of pharmaceutical product development and its associated quality system / Potency method validation / Method validation for HPLC analysis of related substances in pharmaceutical drug products / Dissolution method validation / Chung Chow Chan and Eric Jensen -- Chung Chow Chan -- YC Lee -- Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee -- Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Validation study of JP heavy metal limit test / Bioanalytical method validation / Xue-Ming Zhang -- Yoshiki Nishiyama -- Fabio Garofolo -- The procurement, qualification and calibration of laboratory instruments: an overview / Performance verification of UV-VIS spectrophotometers / Performance verification of HPLC / Herman Lam -- Herman Lam -- Herman Lam.
Electronic reproduction. Palo Alto, Calif. : ebrary, 2009. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Drugs--Analysis--Methodology--Evaluation. Laboratories--Equipment and supplies--Evaluation. Laboratories--Instruments--Evaluation.