原料药研发小试总结报告-Model小试总结报告原料药研发部APIR&DDepartment小试总结报告---封面项目编号：Administrator上次打印于2020-4-2218:11最后更新时间：2020-04-2218:11第2页共36页小试总结报告项目名称：项目编号：项目负责人：项目实施人：项目开始日期：项目结束日期：报告编写人报告日期：小试总结报告原料药研发部APIR&DDepartment小试总结报告---目录项目编号：Administrator上次打印于2020-4-2218:11最后更新时间：2020-04-2218:11第3页共36页目录1.项目简介.............................................................................62.产品信息.............................................................................72.1.基本信息..................................................................72.2.产品市场分析..........................................................73.合成路线总图.....................................................................84.原料及中间体的基本信息.................................................94.1.原料及中间体列表..................................................94.2.主要原料基本信息................................................104.3.中间体基本信息....................................................125.工艺流程图（框图）.......................................................145.1.第一步....................................................................145.2.第二步....................................................................146.工艺描述及参数表...........................................................156.1.第一步：................................................................156.2.第二步....................................................................167.小试实验数据汇总及数据分析........................................187.1.小试实验数据........................................................187.2.小试数据分析........................................................188.所用设备及清洗方法.......................................................198.1.设备选择................................................................198.2.设备清洗方法........................................................19小试总结报告原料药研发部APIR&DDepartment小试总结报告---目录项目编号：Administrator上次打印于2020-4-2218:11最后更新时间：2020-04-2218:11第4页共36页9.成品及成品杂质标准品来源或制备工艺........................219.1.成品标准品的来源或制备工艺.............................219.2.成品杂质分布........................................................219.3.杂质来源或制备工艺............................................229.4.其他........................................................................2210.中间体及成品的质量指标..............................................2310.1.成品质量指标......................................................2310.2.中间体质量指标..................................................2311.原材料的质量指标.........................................................2412.原料、中间体和成品的包装规格及储存方式..............2512.1.产品包装规格及储存方式...................................2512.2.中间体包装规格及储存方式...............................2512.3.原料包装规格及储存方式...................................2513.成本估算.........................................................................2713.1.原料单耗..............................................................2713.2.原料成本估算......................................................2714.安全环...
