4. Requirements of the European Pharmacopoeia 欧洲药典的要求

The European Pharmacopoeia provides quality standards for thefollowing grades of water:

欧洲药典为以下级别的水设置了质量标准：

·        Water for Injections

·        注射用水

·        Purified Water

·        纯化水

·        Water for preparation of extracts

·        提取用水

4.1. Potable Water 饮用水

Potable Water is notcovered by a pharmacopoeial monograph but must comply with the regulations on waterintended for human consumption of a quality equivalent to that defined inDirective 98/83/EC or laid down by the competent authority. Testing should becarried out by the manufacturer to confirm the quality of the water. Potablewater may be used during the manufacture of active substances and in the earlystages of cleaning pharmaceutical manufacturing equipment unless there arespecific technical or quality requirements for higher grades of water. It isthe prescribed source feed water for the production of pharmacopoeial gradewaters.

饮用水没有药典专论，但必须符合欧盟指令 98/83/EC 中规定的人用饮用水质量要求，或各成员国相关机构规定的标准。生产商应进行检测，以确认水质。饮用水可用于 API 和平，可用于清洁较前工艺用药品生产设备，有特定技术或要求使用更高质量水者除外。它是指定用于制备制药用水的源水。

4.2. Water for Injections (WFI)注射用水（WFI）

Water for Injections(WFI) is water for the preparation of medicines for parenteral administrationwhen water is used as a vehicle (water for injections in bulk) and fordissolving or diluting substances or preparations for parenteral administration(sterilised water for injections).

WFI是注射用药品制备用水，这时水是载体（散装注射水），用于溶解或稀释药用物质或制备注射给药的制剂（灭菌的注射水）。

For a detaileddescription of the production and control of Water for Injections refer to Ph.Eur. monograph 0169. It should be noted that when reverse osmosis is to beintroduced at the local manufacturing site, notice should be given to the GMPsupervisory authority of the manufacturer before implementation as described inthe Compilation of Community Procedureson Inspections and Exchange ofInformation.

注射用水的制备和检测详细信息参见 EP 专论 0169。应注意如果在生产工厂本地使用了反渗透制备方法，则应按“欧盟检查和信息交换程序汇编”所述在实施之前向生产商的GMP监管机构提交通知。

4.3. Purified Water 纯化水

Purified Water is waterfor the preparation of medicines other than those that are required to be bothsterile and apyrogenic, unless otherwise justified and authorised.

纯化水是不需要无菌或除热原的药品制备用水，另有论证和批准者除外。

Purified Water whichsatisfies the test for endotoxins described in Ph. Eur. monograph 0008 may beused in the manufacture of dialysis solutions.

符合 EP 专论 0008 中所述内毒素检测要求的纯化水可用于透析液的生产。

For a detaileddescription of the production and control of Purified Water refer to Ph. Eur.monograph 0008.

纯化水的制备和检测详细信息参见 EP 专论 0008。

4.4. Water for preparation of extracts 提取用水

Water for preparationof extracts is water intended for the preparation of Herbal drug extracts(0765) which complies with the sections Purified water in bulk or Purifiedwater in containers in the monograph Purified water (0008), or is waterintended for human consumption of a quality equivalent to that defined inDirective 98/83/EC which is monitored according to the Production sectiondescribed in the monograph.

提取用水是草药提取物（0765）生产用水，应符合纯化水专论（0008）中散装纯化水或容器中的纯化水章节的要求，或指令 98/83/EC 中规定的人用水质要求。该水应根据专论中生产章节进行监测。

For a detailed description of the production and control of Water forpreparation of extracts refer to Ph.
Eur. Monograph 2249.

提取用水的制备和检测详细信息参见 EP 专论 2249。