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

WORD格式.分享 精品.资料 Center for Drug Evaluation and Research (CDER) Reviewer Guidance Validation of Chromatographic Methods November 1994 CMC 3 TABLE OF CONTENTS 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 Chromat