Update on Undertaking Extractable and Leachable Testing 1st Edition by Feilden ISBN 1847354556 9781847354556

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Product details: 

ISBN 10:  1847354556 

ISBN 13: 9781847354556

Author: Feilden

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.

Table of contents: 

1 Introduction

1.1 Sample Preparation.

1.2 General Extraction

1.3 How Low To Go: Limit of Detection.

1.4 Introduction to Extraction Techniques.

2.Extraction Techniques

2.1 Sonication.

2.2 Reflux

2.3 Soxhlet

2.4 Supercritical Fluid Extraction

2.5 Sealed Vessel

2.6 Pressurised Solvent Extraction

2.7 Microwave Assisted Extraction

2.8 Shaking Extraction

2.9 Direct Analysis

2.10 Headspace

2.11 Thermal Desorption

2.12 Dynamic Headspace

2.13 Liquid Extraction Surface Analysis.

2.14 Extraction to Asymptotic Levels

3 Liquid Extraction Techniques.

3.1 Liquid-liquid Extraction

3.2 Solid Phase Extraction

3.3 Solid Phase Microextraction

3.4 Single-drop Microextraction.

3.5 Dispersive Liquid-liquid Microextraction.

3.6 Liquid-phase Microextraction Solidification of Floating Organic Drop

3.7 Hollow-fibre Liquid-phase Microextraction

3.8 In-tube Extraction

3.9 Microextraction by Packed Sorbent

3.10 Stir Bar Sorptive Extraction

3.11 Membrane-assisted Solvent Extraction

3.12 Extraction to Asymptotic Levels

3.13 Conclusions Regarding Extraction..

4 General Analysis

4.1 Quantification

4.2 Response Factors

4.3 Identification

5 Gas Chromatography.

5.1 Introduction

5.2 Instrumentation of a Gas Chromatograph…

5.3 Carrier Gas

5.4 Choice of Sample Introduction.

5.5 Sample Injector.

5.6 Information Required Before Method Developmen

5.7 Developing a Gas Chromatography Method

5.8 Sample Preparation.

5.9 Effects of Changing Individual Chromatographic Parameters

5.10 Column Parameters

5.10.1 Selection of the Stationary Phase

5.10.2 Stationary Phase Film Thickness..

5.10.3 Column ID

5.10.4 Phase Ratio

5.10.5 Column Length

5.10.6 Conclusions Regarding Columns..

5.11 Oven Temperature Gradient (Temperature Programme)

5.12 Injection Volume…

5.13 Injection Temperature.

5.14 Liners

5.15 Problems with the Injection

5.16 Split Flow/Ratio.

5.17 Column Flow Rate

5.18 Cool-on-Column

5.19 Programmable Temperature Vaporisation.

5.20 Choice of Detector.

5.20.1 Flame Ionisation Detector

5.20.2 Mass Spectrometer

5.20.3 Electron Capture Detector.

5.20.4 Thermal Conductivity Detector.

5.20.5 Nitrogen Phosphorous Detectors

5.20.6 Flame Photometric Detector.

5.20.7 Thermal Energy Analyser, Nitrogen Chemiluminescence Detector..

5.21 Derivatisation

5.22 Typical Starting Conditions for Extractable Analysis

6 High-performance Liquid Chromatography

6.1 Introduction

6.2 Sample Preparation..

6.3 Separation

6.3.1 Reverse Phase.

6.3.2 Normal Phase.

6.3.3 Ion Pair Mode

6.3.4 Ion Exchange.

6.3.5 Size-exclusion Chromatography.

6.4 Developing a High-performance Liquid Chromatography Method.

6.5 Solvent Selection…

6.6 Temperature Control

6.7 Columns .

6.8 pH..

6.9 Detector Selection

6.9.1 Ultraviolet Detector.

6.9.2 Wavelength Selection

6.10 Fluorescence Detector.

6.11 Mass spectrometer.

6.11.1 Electrospray Ionisation.

6.11.2 Atmospheric Pressure Chemical Ionisation

6.11.3 Atmoospheric Pressure Photo Ionisation

6.11.4 Conclusions Regarding the Mass Spectrometer

6.12 Evaporative Light-scattering Detector.

6.13 Charged Aerosol Detector

6.14 Nano Quantity Analyte Detector.

6.15 Typical Starting Conditions for Extractable Analysis

7 Inductively Coupled Plasma – Metal Analysis.

8 Conclusion

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Tags: Feilden, Update on Undertaking, Extractable and Leachable