金币
UID326
帖子
主题
积分5589
注册时间2011-6-2
最后登录1970-1-1
听众
性别保密
|
欢迎您注册蒲公英
您需要 登录 才可以下载或查看,没有帐号?立即注册
x
CONTENTS
Contributors vii
Preface ix
1 Overview of Pharmaceutical Product Development and Its Associated Quality System 1
2 Potency Method Validation 11
3 Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products 27
4 Dissolution Method Validation 51
5 Development and Validation of Automated Methods 67
6 Analysis of Pharmaceutical Inactive Ingredients 85
7 Validation Study of JP Heavy Metal Limit Test 95
8 Bioanalytical Method Validation 105
9 Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview 139
10 Performance Verification of UV–Vis Spectrophotometers 153
11 Performance Verification of HPLC 173
12 Operational Qualification of a Capillary Electrophoresis Instrument 187
13 LC-MS Instrument Calibration 197
14 Karl Fisher Apparatus and Its Performance Verification 221
15 The pH Meter and Its Performance Verification 229
16 Qualification of Environmental Chambers 243
17 Equipment Qualification and Computer System Validation 255
18 Validation of Excel Spreadsheet 277
Index
|
评分
-
查看全部评分
|