Analytical method validation and instrument performance verification

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Detalhes bibliográficos
Autor Corporativo: ebrary, Inc
Outros Autores: Chan, Chung Chow
Formato: Recurso Eletrônico livro eletrônico
Idioma:inglês
Publicado em: Hoboken, N.J. : John Wiley & Sons, c2004.
Assuntos:
Acesso em linha:An electronic book accessible through the World Wide Web; click to view
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Sumário:
  • 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.