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药物分析=PHARMACEUTICAL ANALYSI/童珊珊等 内容简介
本书共17章，主要包括两部分内容。一是从药品质量控制的各个研究阶段进行介绍，具体包括现代药物分析概要、药物的鉴别、杂质检查和含量测定方法、药物制剂分析、中药分析、分析方法的验证等，为药物质量评价与控制研究提供基本知识。另一部分则以各类典型药物的分析为例，详细介绍各类药物的质量分析方法。
药物分析=PHARMACEUTICAL ANALYSI/童珊珊等 目录
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
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