Update on undertaking extractable and leachable testing [electronic resource] / Andrew Feilden.

Format:

Book

Author/Creator:

Feilden, Andrew.

Language:

English

Subjects (All):

Extraction (Chemistry).

Physical Description:

1 online resource (180 p.)

Place of Publication:

Shrewsbury [England] : iSmithers, 2011, c2010.

Language Note:

English

Summary:

The assessment of all materials - and especially elastomeric and plastic components - for the presence of leachable and extractable components, forms an important part of the submission for approval of a new drug system or medical device. This Update gives a detailed, state-of-the-art review of the selection of techniques, available to the analyst, to perform a controlled extraction study for leachables and extractables, with an overview of the factors to consider when selecting the extraction technique. This book will be of interest to Chemists and R&D managers.

Contents:

Front Cover; Title Page; Preface; Contents; Chapter 1 Introduction; Chapter 2 Extraction Techniques; Chapter 3 Liquid Extraction Techniques; Chapter 4 General Analysis; Chapter 5 Gas Chromatography; Chapter 6 High-performance Liquid Chromatography; Chapter 7 Inductively Coupled Plasma Metal Analysis; Chapter 8 Conclusion; Abbreviations; Index; Back Cover

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-283-12352-5

9786613123527

1-84735-456-4

OCLC:

729167100