项目生产工艺总结报告模板.doc

XXX项目生产总结报告 （或者XXX项目工艺验证总结报告）（中文版） 产品名称：CAS号：产品代号：生产地点：生产日期：产出：批 目录 1、概述 1 2、合成路线 2 3、工艺操作规程SOP 2 3.1 第一步。。。 2 3.1.1 反应方程式 2 3.1.2 原料投料表 2 3.1.3 工艺规程 2 3.2 第二步。。。 2 3.2.1 反应方程式 2 3.2.2 原料投料表 2 3.2.3 工艺规程 2 4、新工艺与旧工艺的对比变化 2 5、批数据总结（收率、纯度、规模） 2 5.1 中间体和成品数据总结 2 5.2 中控总结 2 5.3 中间体纯度总结 2 6、生产后要点总结（讨论） 2 6.1 第一步。。。。 2 6.2 第二步。。。。 2 6.3 试产中发现问题和注意事项 2 7. 生产批次COA原始数据列表统计 2 注意：每部分的具体内容要求，参见下面英文版说明部分；  XX (project code) Campaign Report （英文版） Product Name： … CAS#: Product code: Manufacturing Site: Date: Target: kg 1. Introduction: 简要介绍工艺或中试研究的背景，目的，成果等 A short summary of the total work. May include the background, goal, achievement, etc. The following is an example: On June 24, 2005, we were assigned GMP preparation (600g) of XXXX. An eleven-step synthetic procedure was originally provided by XXX(ref.1). The original synthesis was developed by XXX(ref. 2). During the developmental work carried out concurrently, we modified the initial four steps to obtain intermediate phenol 4 in high yield and purity. After the last submission of XXX, 300g (5/17/05), we changed the preparation of acetophenone 9. The use of XXX step was replaced with lithiation and subsequent coupling with DMF to produce the require ketone 9. The modified synthetic route used in the current preparation is outlined above. Due to multi-step nature of the synthesis, it was decided to prepare intermediates 7 and 9 under non-GMP conditions. Intermediateds 7 and 9 were then qualified for GMP and used in the preparation of the XXX. Treatment of commercially available XXX with XXX resulted in the carbonate 1 (98%). Nitration of the ethyl carbonate 1 in sulfuric acid afforded crude XXX 1a. Reduction of the above crude nitro compound 1a was carried out in ethyl acetate using 10% palladium on carbon. The catalyst was filtered and the product solution of 2 was treated with pyridine (1.2equ.) and pivalolyl chloride(1.2equ.). The workup resulted in crude intermediate 3.