Catalog

第一章 手性化合物的基本概念与性质·································································1 

第一节 手性的定义与表征··········································································1 

第二节 手性化合物的分类与特点·································································4 

第三节 手性化合物的物理化学性质······························································9 

第四节 手性化合物的生物活性与应用························································· 14 

第二章 不对称合成技术················································································· 21 

第一节 不对称合成技术的类型与作用机制··················································· 21 

第二节 常见的不对称合成技术反应···························································· 27

第三节 不对称合成技术的优势与局限性······················································ 31 

第四节 不对称合成技术的最新进展···························································· 34

第三章 生物催化技术···················································································· 37

第一节 生物催化技术酶的分类与特性························································· 37 

第二节 生物催化技术催化反应的机理························································· 40

第三节 反应条件对生物催化技术催化的影响················································ 45 

第四节 生物催化技术在手性合成中的应用案例············································· 49 

第四章 手性拆分技术···················································································· 53

第一节 手性拆分的基本原理····································································· 53 

第二节 常见的手性拆分方法····································································· 56 

第三节 手性拆分剂的选择与应用······························································· 61 

第四节 手性拆分技术的发展趋势······························································· 65 

第五章 手性合成中的催化剂与反应条件···························································· 71 

第一节 常见的手性催化剂类型·································································· 71 

第二节 催化剂的选择与优化····································································· 76 

第三节 反应温度、压力和溶剂的影响························································· 80 

第四节 反应时间与产率的关系·································································· 85 

第六章 手性化合物合成的工艺优化·································································· 91

第一节 工艺参数的优化策略····································································· 91

第二节 反应流程的改进与创新·································································· 96 

第三节 绿色化学在合成工艺中的应用························································101 

第四节 连续流合成技术在手性化合物中的应用············································105

第七章 手性化合物质量控制基本原理······························································111 

第一节 质量控制的重要性·······································································111 

第二节 手性化合物核心指标····································································114 

第三节 质量控制的统计方法····································································118 

第四节 质量标准制定原则·······································································124 

第八章 手性化合物全过程 GMP 管理·······························································133 

第一节 GMP 基本原则与要求 ··································································133 

第二节 GMP 管理体系············································································136 

第三节 质量保证体系·············································································140 

第四节 GMP 的实施与监督······································································143

第九章 手性化合物分析方法开发····································································153 

第一节 分析方法开发的流程····································································153

第二节 方法开发中的策略·······································································160 

第三节 方法开发实施案例·······································································165 

第十章 检测方法验证···················································································167

第一节 方法验证的目的与意义·································································167 

第二节 验证的参数与指标·······································································172 

第三节 验证方案的设计与实施·································································176 

第四节 异构体检测方法验证实例······························································184 

第十一章 手性化合物的纯度检测与杂质分析·····················································191

第一节 纯度检测的方法与标准·································································191 

第二节 常见杂质的类型与来源·································································194

第三节 杂质的分离与检测·······································································197 

第四节 杂质对产品质量的影响评估···························································201

第十二章 手性化合物 DMF 登记·····································································207 

第一节 DMF 登记的发展和意义································································207 

第二节 登记的流程与资料要求·································································212 

第三节 登记中的注意事项·······································································216 

第四节 成功登记的案例分析····································································222 

第十三章 未来展望与发展趋势·······································································225 

第一节 手性化合物合成与质量控制的挑战与机遇·········································225 

第二节 新技术、新方法的展望·································································229 

第三节 行业发展趋势与前景预测······························································233 

第四节 研究方向与重点的展望·································································238 

参考文献····································································································243