1. Introduction (background)
前言（背景）
Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for
reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing
vessels, equipment, primary packaging materials etc.
水是制药工业使用的重要商品之一。可用作制剂的辅料或用于产品的配制、合成过程、制剂的生产过程或用作冲
洗罐、设备、内包材的清洗剂等。
Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of
water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable
resource to the development and maintenance of water purification systems.
根据不同的制药用途，需要不同等级的水。控制水的质量，尤其是其微生物指标是个重要问题，使制药工业投入
大量资源开发和维护水的纯化系统。
The European Pharmacopoeia (Ph. Eur.) provides quality standards for grades of water for pharmaceutical use including
Water for Injections (WFI), Purified Water and Water for preparation of extracts.
欧洲药典提供不同等级制药用水的质量标准，包括注射用水(WFI)、纯化水和提取物制备用水。
Until April 2017, the production of Water for Injections (WFI) had been limited to production by distillation only. Following
extensive consultation with stakeholders, the Ph. Eur. monograph for Water for Injections (0169) was revised in order to
allow the production of WFI by a purification process equivalent to distillation, such as reverse osmosis coupled with
appropriate techniques such as electro-deionisation, ultrafiltration or nanofiltration. The revised monograph was published
in the Ph. Eur. Supplement 9.1 and became effective on 1 April 2017.
2017 年 4 月以前，仅限于采用蒸馏法制备注射用水。经与利益相关者进行广泛征求意见后，欧洲药典的注射用
水各论（0169）被修订以允许使用与蒸馏法效果相当的其他纯化工艺制备注射用水，例如反渗透法配合其他适当
的技术，如电解法、超滤法或纳滤法。修订后的各论发布于欧洲药典增补本 9.1，并于 2017 年 4 月 1 日生效。
This change brings the Ph. Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia, allowing
production of WFI by distillation or by a purification process proven “equivalent or superior to distillation”, and “by distillation
or by reverse osmosis and/or ultrafiltration”, respectively.
这次改变使欧洲药典与美国药典和日本药典更一致，两个药典分别规定允许使用蒸馏法或其他经证明“等同或优
于蒸馏法”的纯化工艺，以及“用蒸馏法或者反渗透法和/或超滤法”。 842
