奥美拉唑的工艺规程1..doc

奥美拉唑生产工艺规程 编号：SOP-MF-301-19 起草： 日期： 审阅： 日期： 审核： 日期： 审批： 日期： 执行日期： 分发部门：生产部，设备部、办公室、质检部 目录 产品概述························································1 1.1通用名称······················································1 1.2化学名························································1 1.3中文别名······················································1 1.4汉语拼音······················································1 1.5英文名称·····················································1 1.6常见的商品名·················································1 1.7英文别称·····················································1 1.8分子式·······················································1 1.9分子量·······················································1 1.10结构式······················································1 1.11理化性质····················································1 1.12执行的标准··················································1 1.13临床用途····················································1 产品包装及规格··················································1 2.1包装··························································1 2.2包装规格······················································1 2.3规格··························································1 2.4储存··························································1 原辅料、包装材料质量标准········································1 3.1原辅料、成品质量标准·········································2 3.2包装材料·····················································4 3.3说明书·······················································4 4．化学反应式与工艺流程图··········································4 4.1化反应式·····················································4 4.2生产流程图···················································6 4.2.1工艺流程方框图··············································6 4.4.2设备流程图·····