02241cam a22003854a 4500 13248195 OSt 20150408113723.0 030619s2004 njua b 001 0 eng 2003014141 0471259535 (cloth : alk. paper) (DNLM)101182631 DNLM/DLC DLC DLC pcc RS189 .A568 2004 QV 744 A532 2004 610.28 21 Analytical method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. Hoboken, N.J. : John Wiley & Sons, c2004. x, 303 p. : ill. ; 24 cm. Includes bibliographical references and index. Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / 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 / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo -- The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-VIS spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam. Drugs Analysis Methodology Evaluation. 6021 Laboratories Equipment and supplies Evaluation. 6022 Laboratories Instruments Evaluation. 6023 Chemistry, Pharmaceutical instrumentation. 6024 Chemistry, Pharmaceutical methods. 6025 Clinical Laboratory Techniques standards. 6026 Technology, Pharmaceutical methods. 6027 Chan, Chung Chow. 6028 ddc BOOK 824 235324 0 2013-03-10 0 0 610/.28 2011-05-17 CL CL 2013-03-10 00:00:00 0