《analysis of drug impurities》Alan J. Handley and John M. Chalmers
Contents
Preface xi
List of contributors xii
1. Organic impurities in drug substance: origin, 1
control, and measurement
Linda Ng, George Lunn, and Patrick Faustino
1.1 Introduction 1
1.2 Origin of impurities 1
1.2.1 Process impurities 2
1.2.2 Degradation impurities 2
1.2.3 Contamination impurities 3
1.2.4 Other impurities 3
1.3 Control of drug substance impurities 4
1.3.1 Control of residual solvents 4
1.3.2 Control of synthetic impurities 5
1.3.3 Control of impurities in biological and
botanical products 7
1.3.4 Purification processes 9
1.3.5 Control of impurities from packaging 10
1.3.6 Control of contamination impurities 11
1.3.7 Control of degradants on stability 11
1.4 Measurement of drug substance impurities 11
1.4.1 HPLC 12
1.4.2 GC 13
1.4.3 CE 15
1.4.4 General considerations 16
1.5 Conclusions 19
Disclaimer
References 19
2. Organic impurities in drug products: origin, 21
control and measurement
David P. Elder
2.1 Introduction 21
2.2 Analytical methodology 22
2.3 Drug–excipient compatibility experimental design 24
2.4 Degradation mechanisms 25
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