Analytical method validation and instrument performance verification /
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.
- 610/.28 .
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.
0471259535 (cloth : alk. paper)
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.
610/.28
QV 744 / A532 2004
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.
0471259535 (cloth : alk. paper)
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.
610/.28
QV 744 / A532 2004