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                您的位置:首页  ->  公司动态 -> 制药用水不只是纯化水

                制药用水不只是纯化水



                一、在《中国药典》2015 版附录中,有以下几种制药用水。

                制药纯化水

                饮用水:
                为天然水经净化处理所得的水,其质量符合国家标准《生活饮用水卫生标准》。

                纯化水:
                为饮用水经蒸馏法、离子交换法、反渗透法或其他适宜的方法制得的制药用水,不含任何添加剂,其质量应符合纯化水项下的规定。
                制药纯化水

                注射用水:
                为纯化水经蒸馏所得的水,应符合细菌内毒素试验要求,注射用水必须在防止细菌内毒素产生的设计条件下生产、贮藏及分装,其质量应符合注射用水项下的规定。

                灭菌注射用水:
                为注射用水照注射剂生产工艺制备所得,不含任何添加剂。

                二、制药用水能应用在哪里?
                制药纯化水

                饮用水:
                1、药品包装材料粗洗用水、中药材和中药饮片的清洗、浸润、提取等用水。
                2、《中国药典》同时说明,饮用水可作为药材净制时的漂洗、制药用具的粗洗用水,除另有规定外,也可作为药材的提取溶剂。

                纯化水:
                1、非无菌药品的配料、直接接触药品的设备、器具和包装材料最后一次洗涤用水、非无菌原料药精制工艺用水、制备注射用水的水源、直接接触非最终灭菌棉织品的包装材料粗洗用水等。
                2、纯化水可作为配制普通药物制剂用的溶剂或试验用水;可作为中药注射剂、滴眼剂等灭菌制剂所用饮片的提取溶剂;口服、外用制剂配制用溶剂或稀释剂;非灭菌制剂用器具的精洗用水,也用作非灭菌制剂所用饮片的提取溶剂。纯化水不得用于注射剂的配制与稀释。

                注射用水:
                1、直接接触无菌药品的包装材料的最后一次精洗用水、无菌原料药精制工艺用水、直接接触无菌原料药的包装材料的最后洗涤用水、无菌制剂的配料用水等。
                2、注射用水可作为配制注射剂、滴眼剂等的溶剂或稀释剂及容器的精洗。

                灭菌注射用水:
                灭菌注射用灭菌粉末的溶剂或注射剂的稀释剂,其质量应符合灭菌注射用水项下的规定。


                相关搜索:

                纯化水系统一级电导率异常升高

                注射用水纯化水系统--多效蒸馏

                典型纯化水设备的设计过程概述


                本文关键词:  
                制药用纯化水   纯化水系统   制药纯水设备

                本文网址:http://www.x52wg.com/news_content-758674.html

                东莞市杰邦水处理有限公司官网 :www.jiebon.com



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