CDER评审官指南《色谱分析方法的验证》CenterforDrugEvaluation.docx

CDER 评审官指南《色谱分析方法的验证》 Center for Drug Evaluation and Research (CDER) Reviewer Guidance Validation of Chromatographic Methods November 1994 CMC 3 TABLE OF CONTENTS CDER 评审官指南《色谱分析方法的验证》 I. INTRODUCTION 目录.........................................................1 II. TYPES OF CHROMATOGRAPHY 绪言……...........................................2 A. 色谱分类 High Performance Liquid Chromatography (HPLC) 高效液相色谱 1. Chiral Chromatography 手性液相色谱 2. Ion-exchange Chromatography 离子交换色谱......................................3 3. Ion-pair/Affinity Chromatography 离子对/ 亲和色谱............................. ......3 4. Normal Phase Chromatography 正相色谱........................................3 5. Reversed Phase Chromatography 反相色谱....................................... .3 6. Size Exclusion Chromatography 分子排阻色谱……..................................4 B. Gas Chromatography (GC) 气相色谱.......................………………………..4 C. Thin-Layer Chromatography (TLC) 薄层色谱...............…………………….... .5 III. REFERENCE STANDARDS 参考标准............................…………….... .5 IV. PARAMETERS FOR VALIDATION OF HPL CHROMATOGRAPHIC METHODS FOR DRUG SUBSTANCE AND DRUG PRODUCT 药物及其制剂 HPLC 方法验证的参数………………….... .7 A. Accuracy 准确性………...............................………………………........ .8 B. Detection Limit and Quantitation Limit 检出限和定量限.....………………………........8 C. Linearity 线性…….........................................……………………….. 11 D. Precision 精密度.........................................………………………. 13 1. Repeatability 重复性...................................…………………………… 13 a. Injection Repeatability 进样重复性...................……………………………………. 13 b. Analysis Repeatability 分析重复性...................……………………………………. 15 2. Intermediate Precision 组间精密度.......................…………………………….. 15 3. Reproducibility 重现性................................……………………………… 16 E. Range 范围……............................................…………………….. 16 F. Recovery 回收率............................................…………………….. 16 G. Robustness 耐久性....................