埃索美拉唑钠CTD申报资料.pdf

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1、埃索美拉唑钠CTD申报资料目录3.2.S.1基本信息.......................................................................................................13.2.S.1.1药品名称..............................................................................................13.2.S.1.2结构.........................................

2、.............................................................13.2.S.1.3理化性质..............................................................................................13.2.S.2生产信息.......................................................................................................23.2.S

3、.2.1生产商..................................................................................................23.2.S.2.2生产工艺和过程控制..........................................................................33.2.S.2.3物料控制..............................................................................

4、................83.2.S.2.4关键步骤和中间体的控制................................................................313.2.S.2.5工艺验证和评价................................................................................323.2.S.2.6生产工艺的开发.........................................................................

5、.......343.2.S.3特性鉴定.....................................................................................................403.2.S.3.1结构和理化性质................................................................................403.2.S.3.2杂质..........................................................

6、..........................................523.2.S.4原料药的质量控制.....................................................................................563.2.S.4.1质量标准............................................................................................563.2.S.4.2分析方法........................

7、....................................................................57CDE3.2.S.4.3分析方法的验证................................................................................713.2.S.4.4批检验报告...........................................................................