翻译:JULIA 来源:Julia法规翻译
Monograph for Water, highly purified (1927) to be suppressed from the European Pharmacopoeia
EP不再保留高纯水各论(1927)
20180605
Following a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.
经2018年3月EP委员会第160次会议决定,高纯水(HPW)各论将自2019年4月1日起不再保留于EP中,因为最近EP对注射水各论(0619)进行了修订,允许使用等同于蒸馏的的纯化工艺制备注射水(WFI),不仅限于蒸馏。鉴于此,HPW各论从质量要求和制备方法来说,均与WFI重复,因此成为冗余内容。
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