Analytical Method Development and Validation

Inbunden, Engelska, 2017

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Beskrivning

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.

Produktinformation

Utgivningsdatum:2017-09-28
Mått:138 x 216 x 12 mm
Vikt:226 g
Format:Inbunden
Språk:Engelska
Antal sidor:96
Förlag:Taylor & Francis Ltd
ISBN:9781138402560

Utforska kategorier

Analytisk kemi inom Naturvetenskap och teknik

Mer om författaren

Michael E. Swartz, Ira S. Krull

Recensioner i media

". . .a useful primer-type book covering validation of analytical methods. . . .recommended."---Analyst"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."---INFORM

Innehållsförteckning

Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.