童珊珊、餘江南主編的《藥物分析(英文版)》共
17章，主要包括兩部分內容。一是從藥品質量控制的
各個研究階段進行介紹，具體包括現代藥物分析概要
、藥物的鋻別、雜質檢查和含量測定方法、藥物制劑
分析、中藥分析、分析方法的驗證等，為藥物質量評
價與控制研究提供基本知識。另一部分則以各類典型
藥物的分析為例，詳細介紹各類藥物的質量分析方法
。

CHAPTER 1 INTRODUCTION TO PHARMACEUTICAL ANALYSIS
1.1 Analytical Techniques
1.2 Pharmaceutical Analysis and Its Duties
CHAPTER 2 STANDARDS AND GUIDELINES FOR PHARMACEUTICALS
2.1 Chinese Pharmacopoeia & National Standards
2.2 Other Pharmacopoeias
2.3 Guidelines of Quality Control Practice
2.4 ICH Guidelines
CHAPTER 3 IDENTIFICATION TESTS
3.1 Identification Methods
3.2 General Identification Tests
CHAPTER 4 DRUG PURITY AND ITS CONTROL
4.1 Impurities and Their Sources
4.2 Test of Impurity and Its Limit Estimation
4.3 Limit Tests for Inorganic Impurities
4.4 Limit Tests for Residual Solvents
4.5 Limit Tests for Organic Impurities
CHAPTER 5 QUANTITATIVE ANALYSIS OF DRUGS
5.1 Titrimetric Methods
5.2 Ultraviolet-Visible Spectrophotometry
5.3 Chromatographic Techniques
CHAPTER 6 VALIDATIoN OF ANALYTICAL PRoCEDURES
6.1 Accuracy
6.2 Precision
6.3 Specificity
6.4 Limit of Detection
6.5 Limit of Quantitation
6.6 Linearity
6.7 Range
6.8 Ruggedness
CHAPTER 7 ANALYSIS OF DRUGS IN BIoLoGICAL FLUIDS
7.1 Introduction of Bioanalysis
7.2 Role of Bioanalysis in Pharmaceutical Drug Development
7.3 Specimen Clection
7.4 Pretreatment Methods of Biological Sample
7.5 Bioanalytical Method Validation
CHAPTER 8 ANALYSIS OF AROMATIC CARBOXYLIC ACIDS
8.1 Structure and Properties
8.2 Identification
8.3 Test of Related Substances
8.4 Assay
CHAPTER 9 ANALYSIS OF LOCAL ANESTHETICS
9.1 General Introduction
9.2 Structure and Properties
9.3 Identification
9.4 Test
9.5 Assay
CHAPTER 10 ANALYSIS OF BARBITURATES
10.1 Structures and Properties
10.2 Identification
10.3 Test
10.4 Assay
CHAPTER 11 ANALYSIS OF HETEROCYCLIC DRUGS
11.1 Analysis of Pyridine Drugs
11.2 Analysis of Quinoline Drugs
11.3 Assay
CHAPTER 12 ANALYSIS OF VITAMINS
12.1 General Introduction
12.2 Analysis of Vitamin A
12.3 Analysis of Vitamin BI
12.4 Analysis of Vitamin C
12.5 Analysis of Vitamin E
CHAPTER 13 ANALYSIS OF ANTIBIOTICS
13.1 General Introduction
13.2 B-Lactams
13.3 Aminoglycosides
13.4 Tetracyclines
13.5 Examination of Polymer Impurities in Antibiotics
CHAPTER 14 ANALYSIS 0F PHARMrACEUTICAL PREPARATIONS
14.1 Features of the Analysis of Pharmaceutical Preparations
14.2 Test ofTablets and Injections
14.3 Assay for Tablets and Injections
14.4 Analysis of Compound Preparations(Mixed Preparations)
CHAPTER 15 ANALYSIS OF TRADITIONAL CHINESE MEDICINE AND ITS PREPARATIoNS
15.1 Introduction
15.2 FDA Guidance I
15.3 FDA Guidance II
15.4 Chinese Pharmacopoeia 2015
15.5 Progress on Quality Control of TCM
CHAPTER 16 ANALYSIS OF BIoLOGICAL PRODUCTS
16.1 The Varieties and Characteristics of Biological Products
16.2 Identification Analyses
16.3 Impurity Test
16.4 Concentration(titer)Detection
CHAPTER 17 PRESENT SITUATION AND PROSPECT OF TECHNOLOGY OF PHARMACEUTICAL ANALYSIS
17.1 Ultra-Performance Liquid Chromatography
17.2 Gas Chromatography/Mass Spectrometry
17.3 Liquid Chromatography/Mass Spectrometry
17.4 High-Performance Capillary Electrophoresis
17.5 Chiral Analysis
ACKNOWLEDGMENTS