cial Date: O?cial as of 1-Nov-2018Document Type: USP & NFDocId: 1_GUID-04FB68D0-C896-4513-B1BE-C82A0D442310_4_en-USPrinted from: https://online.uspnf.com/uspnf/document/1_GUID-04FB68D0-C896-4513-B1BE-C82A0D442310_4_en-US© 2020 USPCWater for Injection[N ......
WaterforInjection note—Formicrobiologicalguidance,seegeneralinformationchapterWaterfor PharmaceuticalPurposes1231. 注意:对于微生物的指导,请参阅医药信息1231章的水章节。 DEFINITION定义 »WaterforInjectioniswaterpurifiedbydistillationorapurificationprocess isequivalentorsuperiortodistillationintheremovalofchemicalsand micr...
饮用水（Drinking Water ）——在药学中未有专论涉及饮用水这一品种，但必须符合EPA NPDWR 的质量标准或者符合欧共体或日本的相类似的规定。饮用水可来自不同的水源，包括公用水生产设施，私人供水设施（如井），或者是混合供水源。在化学合成的早期阶段以及早期阶段的药品生产设备的清洗可用饮用水，饮用水是生产药用...
Where required by the processing of the materials to achieve their required final purity, higher qualities of water may be needed for these manufacturing steps, perhaps even as pure asWater for InjectionorPurified Water. Such higher purity waters, however, might require only selected attributes to ...
In general, you can wait aslong as you want – at your risk. But it is advised to test as soon as practicalfor the following reasons; 1) when stored, the water purity only degrades overtime. Since Purified Water, Water for Injecti...
2. What is the purpose of microbial Alert and ActionLevels for Purified Water and Water for Injection? 纯化水和注射水的微生物警戒限和行动限目的是什么? Alert and Action Levels are process control terms andshould be established at levels indicative of the water system trending outsideof its norma...
注射用制菌水(BacteriostaticWaterforInjection)——注射用制菌水(见USP)是无菌注射用水,加有一种或一种以上的制菌剂。注射用制菌水是用作无菌制品的稀释剂,其包装可以为单一剂量或多剂量容器,容器容积不超过30ml。无菌透析水(SterileWaterforIrrigation)——无菌透析水(见USP)是注射用水用单一剂量容器包装,容量超过...
注射用制菌水(Bacteriostatic Water for Injection )——注射用制菌水(见USP )是无 菌注射用水,加有一种或一种以上的制菌剂。注射用制菌水是用作无菌制品的稀释 剂,其包装可以为单一剂量或多剂量容器,容器容积不超过30ml 。 无菌透析水(Sterile Water for Irrigation )——无菌透析水(见USP )是注射用水用 ...
2. What is the purpose ofmicrobial Alert and Action Levels for Purified Water and Water for Injection? 制定纯化水和注水的微生物警戒和行动限的目的是什么? Alert and Action Levels areprocess control terms and should be established at levels indicative of thewater system trending outside of its nor...
东莞景源专业提供美国药典USP标准品,欢迎咨询订购: 。 产品详情: 产品名称:蔗糖标准品 英文名称:Sucrose CAS#: 57-50-1 货号:1623637 规格:100mg 品牌:美国药典USP 用途:在美国药典USP中,对纯化水(Bulk Purified Water)、注射用水(Water for Injection)、无菌纯化水(Sterile Purified Water)和灭菌注射用水(Steri...