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.


Electronic books.

RS189 / .A568 2004eb

610/.28