药物分析=PHARMACEUTICAL ANALYSI/童珊珊等_PDF下载[125MB-百度云]童珊珊,余江南,主编

内容简介

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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。

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CHAPTER 1 INTRODUCTION TO PHARMACEUTICAL ANALYSIS1．1 Analytical Techniques1．2 Pharmaceutical Analysis and Its DutiesCHAPTER 2 STANDARDS AND GUIDELINES FOR PHARMACEUTICALS2．1 Chinese Pharmacopoeia & National Standards2．2 Other Pharmacopoeias2．3 Guidelines of Quality Control Practice2．4 ICH GuidelinesCHAPTER 3 IDENTIFICATION TESTS3．1 Identification Methods3．2 General Identification TestsCHAPTER 4 DRUG PURITY AND ITS CONTROL4．1 Impurities and Their Sources4．2 Test of Impurity and Its Limit Estimation4．3 Limit Tests for Inorganic Impurities4．4 Limit Tests for Residual Solvents4．5 Limit Tests for Organic ImpuritiesCHAPTER 5 QUANTITATIVE ANALYSIS OF DRUGS5．1 Titrimetric Methods5．2 Ultraviolet-Visible Spectrophotometry5．3 Chromatographic TechniquesCHAPTER 6 VALIDATIoN OF ANALYTICAL PRoCEDURES6．1 Accuracy6．2 Precision6．3 Specificity6．4 Limit of Detection6．5 Limit of Quantitation6．6 Linearity6．7 Range6．8 RuggednessCHAPTER 7 ANALYSIS OF DRUGS IN BIoLoGICAL FLUIDS7．1 Introduction of Bioanalysis7．2 Role of Bioanalysis in Pharmaceutical Drug Development7．3 Specimen Clection7．4 Pretreatment Methods of Biological Sample7．5 Bioanalytical Method ValidationCHAPTER 8 ANALYSIS OF AROMATIC CARBOXYLIC ACIDS8．1 Structure and Properties8．2 Identification8．3 Test of Related Substances8．4 AssayCHAPTER 9 ANALYSIS OF LOCAL ANESTHETICS9．1 General Introduction9．2 Structure and Properties9．3 Identification9．4 Test9．5 AssayCHAPTER 10 ANALYSIS OF BARBITURATES10．1 Structures and Properties10．2 Identification10．3 Test10．4 AssayCHAPTER 11 ANALYSIS OF HETEROCYCLIC DRUGS11．1 Analysis of Pyridine Drugs11．2 Analysis of Quinoline Drugs11．3 AssayCHAPTER 12 ANALYSIS OF VITAMINS12．1 General Introduction12．2 Analysis of Vitamin A12．3 Analysis of Vitamin BI12．4 Analysis of Vitamin C12．5 Analysis of Vitamin ECHAPTER 13 ANALYSIS OF ANTIBIOTICS13．1 General Introduction13．2 B-Lactams13．3 Aminoglycosides13．4 Tetracyclines13．5 Examination of Polymer Impurities in AntibioticsCHAPTER 14 ANALYSIS 0F PHARMrACEUTICAL PREPARATIONS14．1 Features of the Analysis of Pharmaceutical Preparations14．2 Test ofTablets and Injections14．3 Assay for Tablets and Injections14．4 Analysis of Compound Preparations（Mixed Preparations）CHAPTER 15 ANALYSIS OF TRADITIONAL CHINESE MEDICINE AND ITS PREPARATIoNS15．1 Introduction15．2 FDA Guidance I15．3 FDA Guidance II15．4 Chinese Pharmacopoeia 201515．5 Progress on Quality Control of TCMCHAPTER 16 ANALYSIS OF BIoLOGICAL PRODUCTS16．1 The Varieties and Characteristics of Biological Products16．2 Identification Analyses16．3 Impurity Test16．4 Concentration（titer）DetectionCHAPTER 17 PRESENT SITUATION AND PROSPECT OF TECHNOLOGY OF PHARMACEUTICAL ANALYSIS17．1 Ultra-Performance Liquid Chromatography17．2 Gas Chromatography/Mass Spectrometry17．3 Liquid Chromatography/Mass Spectrometry17．4 High-Performance Capillary Electrophoresis17．5 Chiral AnalysisACKNOWLEDGMENTS