FDA对药物杂质的控制要求.pptxVIP

;FDA对药物杂质的控制要求：Contents 目录;Drug Production and Quality Control Synthesis of API;FDA对药物杂质的控制要求 原料药与成品药中的有机杂质;有机杂质来源;常见的降解反应;常见的降解反应;确定降解产物-强制降解研究（Forced Degradation Study);确定降解产物-原料药和制剂的稳定性试验;原料药与成品药中的有机杂质;Impurities: Origination Identification Classification of impurities;Impurities: Origination Identification Lists of Impurities in ICH;有机杂质控制限度设置;有机杂质控制限度设置;Control of Impurities: Compendia ICH Establishing Acceptance Criteria for Impurities;Control of Impurities: Compendia ICH  ICH Q3A(R) and Q3B(R). Scope;制剂的杂质限度Q3B(R2). ICH Threshold for D