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2018年6月5日新闻:
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.
欧洲药典委员会在其160次会议(2018年3月)决定:纯化水各论将在2019.04.01日起从欧洲药典删除。删除原因是因为最近更新了注射用水各论(0169),使得除蒸馏之外,纯化步骤与注射用水的蒸馏步骤等同。故在质量要求和生产方法方面,纯化水各论与注射用水各论重复,因此删除纯化水各论。
现行的注射用水各论见Ph. Eur.9.1,修订内容如下:
补充内容 (2018-6-8 11:34):
更正:是高纯水,不是纯化水。 |
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