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利巴韦林工艺验证实验报告.doc

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利巴韦林工艺验证实验报告.doc

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文档介绍:利巴韦林工艺验证实验报告
利巴韦林注射液生产工艺
验证方案
方案制订 签名 `````````````````````````````````````````````````````````````````````````````````````````````````````24
```````````````````````````````````````````````````````````````````````````````````````````````````````````26
``````````````````````````````````````````````````````````````````````````````````````````````````28
``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29
``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29
````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````29
. 设备一览表及生产能力```````````````````````````````````````````````````````````````````````````````30
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、工艺用水系统验证的确认和检查情形表`````````````````35
```````````````````````````````````````````````````````````````````````````````````````36
(按四批预备)验证使用的原料、辅料和安瓿
供应商确认及检查情形表`````````````````````````````````````````````````````````````````````````````37
```````````````````````````````````````````````````````````````38
``````````````````````````````````````````````````````````````````````````````````````39
````````````````````````````````````````````````````````````````````````````````````40
、监控内容、监控方法、监控频次表`````````````````````````````41

(1ml:100mg)常温状态下是无色的澄明液体,属抗病毒药,用于呼吸道合胞病毒引起的病毒性肺炎与支气管炎。
,具体工艺处方如下:
处方:
物料名称 1ml:100 mg
利巴韦林