大多数的SCI收录的分析化学相关期刊对于投稿是否经过Solid method validation是非常看重的，本书详细地介绍了分析方法学考证时需要注意的事项，其中第十三章是关于LC-MS的使用方法稳定性考察问题。相信在仔细阅读过本书后大家一定会对方法学的考证产生新的认识（至少我是这样认为的）。 书名： ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION 主编： CHUNG CHOW CHAN Eli Lilly Canada, Inc. HERMAN LAM GlaxoSmithKline Canada, Inc. Y. C. LEE Patheon YM, Inc. XUE-MING ZHANG Novex Pharma 目录： Contributors vii Preface ix 1 Overview of Pharmaceutical Product Development and Its Associated Quality System 1 Chung Chow Chan and Eric Jensen 2 Potency Method Validation 11 Chung Chow Chan 3 Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products 27 Y. C. Lee 4 Dissolution Method Validation 51 Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, and Y. C. Lee 5 Development and Validation of Automated Methods 67 Chantal Incledon and Herman Lam 6 Analysis of Pharmaceutical Inactive Ingredients 85 Xue-Ming Zhang 7 Validation Study of JP Heavy Metal Limit Test 95 Yoshiki Nishiyama 8 Bioanalytical Method Validation 105 Fabio Garofolo 9 Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview 139 Herman Lam 10 Performance Verification of UV–Vis Spectrophotometers 153 Herman Lam 11 Performance Verification of HPLC 173 Herman Lam 12 Operational Qualification of a Capillary Electrophoresis Instrument 187 Nicole E. Baryla 13 LC-MS Instrument Calibration 197 Fabio Garofolo 14 Karl Fisher Apparatus and Its Performance Verification 221 Rick Jairam, Robert Metcalfe, and Yu-Hong Tse 15 The pH Meter and Its Performance Verification 229 Yu-Hong Tse, Rick Jairam, and Robert Metcalfe 16 Qualification of Environmental Chambers 243 Gilman Wong and Herman Lam 17 Equipment Qualification and Computer System Validation 255 Ludwig Huber 18 Validation of Excel Spreadsheet 277 Heiko Brunner Index 299 ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION
ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION
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