QUALIFICATION DES EQUIPEMENTS DE CHROMATOGRAPHIE LIQUIDE HAUTE PERFORMANCE PDF Download
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Author: RINA.. KONFINO
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: RINA.. KONFINO
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: JULIETTE.. LEPINE MELLIN
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 9780824701154
Category : Science
Languages : en
Pages : 100
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Book Description
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.
Author: Sassan Ghadimi
Publisher:
ISBN:
Category :
Languages : fr
Pages : 182
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Author: Henri Wajcman
Publisher:
ISBN:
Category : Amino acid sequence
Languages : en
Pages : 232
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Author: MARTINE.. VIDAL AIACHE
Publisher:
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Category :
Languages : fr
Pages :
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Author: Elodie Jolbert
Publisher:
ISBN:
Category :
Languages : fr
Pages : 36
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Author: Duc Hao Vu
Publisher:
ISBN:
Category :
Languages : fr
Pages : 146
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Author: Heinz Engelhardt
Publisher: Springer
ISBN: 9783642670664
Category : Science
Languages : en
Pages : 0
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Book Description
Modern liquid column chromatography (LC) has developed rapidly since 1969 to become a standard method of separation. If the statisticians are to be believed, the recent growth of LC has been the most specta cular development in analytical chemistry and has not yet abated be cause its vast potential for application remains to be fully exploit ed. Significant factors contributing to this continued rise are the simplicity and low cost of the required basic equipment and the rela tive ease of acquiring and interpreting the data. Unfortunately, in LC, as so often in the field of analytical chemistry, the available commercial instruments are frequently far more complicated - and consequently far more expensive - than is nec essary for routine application. Therein also lies the risk of propa gating a "black box" philosophy that would be particularly detrimen tal to chromatography. Moreover, it appears to have been forgotten, as was done previously with gas chromatography, that inadequate sep aration by a column can be remedied only with great difficulty, if at all, by electronic means. Also, whether the capillary columns recent ly advocated with great enthusiasm for LC will fulfill the expecta tions of their proponents is highly questionable unless someone comes up with some new and revolutionary ideas.
Author: David M. Bliesner
Publisher: Wiley-Interscience
ISBN: 0470042192
Category : Science
Languages : en
Pages : 354
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Book Description
All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.
