Analytical method validation and instrument performance verification
General Material Designation
[Electronic Resource]
First Statement of Responsibility
/ edited by Chung Chow Chan ... [et al.]
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Hoboken, N.J.
Name of Publisher, Distributor, etc.
: John Wiley & Sons,
Date of Publication, Distribution, etc.
, c2004.
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
x, 303 p. ill. 24 cm.
NOTES PERTAINING TO PUBLICATION, DISTRIBUTION, ETC.
Text of Note
e
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
ng
Text of Note
Includes bibliographical references and index.
CONTENTS NOTE
Text of Note
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.
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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 --
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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 --