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Analytical method development and validation

By: Contributor(s): Material type: TextTextLanguage: English Publication details: Boca Raton CRC 2023Description: 92p. PB 21.5x14cmISBN:
  • 9781032501574
Subject(s): DDC classification:
  • 23 543 SWAA
Summary: Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
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Item type Current library Collection Call number Status Barcode
Book Book St Aloysius PG Library Analytical Chemistry 543 SWAA (Browse shelf(Opens below)) Available PG024668
Total holds: 0

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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