USP30_1231-WATER FOR PHARMACEUTICAL PURPOSES翻译(节选).doc

USP30-- 1231 WATER FOR PHARMACEUTICAL PURPOSES USP30 1231 制药用水（节选饮用水部分） SOURCE OR FEED WATER CONSIDERATIONS 水源或供水系统 To ensure adherence to certain minimal chemical and microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. Environmental Protection Agency (EPA) or the drinking water regulations of the European Union or Japan, or the WHO drinking water guidelines. 为了保证能达到某些化学和微生物的最低质量标准，用于药品生产的水或者是用于制备各种纯化水的水源必须要符合环境保护局（EPA）发布的国家基本饮用水规定（NPDWR ）(40 CFR 141)欧日本的有关饮用水规定也可适用。Limits on the types and quantities of certain organic and inorganic contaminants ensure that the water will contain only small, safe quantities of potentially objectionable chemical species. Therefore, water pretreatment systems will only be challenged to remove small quantities of these potentially difficult-to-remove chemicals. Also, control of objectionable chemical contaminants at the source-water stage eliminates the need to specifically test for some of them (e.g., trihalomethanes and heavy metals) after the water has been further purified. 对某些有机和无机污染物的种类和数量进行限定可以保证水中只含有微小的，可靠数量的潜在的化学物质。因此水的预处理系统只需除掉这些少量的、难以去除的化学物质。而且，从水源开始对这些令人讨厌的化学污染物进行控制就可以免去在后续纯化过程中对这些化学物质（如：三卤代甲烷和重金属）的检验。 Microbiological requirements of drinking water ensure the absence of coliforms, which, if determined to be of fecal origin, may indicate the potential presence of other potentially pathogenic microorganisms and viruses of fecal origin. 饮用水规定中的微生物标准保证水中不存在大肠菌。如经确定该菌来自粪便，则预示可能有来自粪便的其他微生物病毒。Meeting these microbiological requirements does not rule out the presence of other microorganisms, which could be considered undesirable if found in a drug substance or formulated product. 符合国家饮用水标准并不排除有其他微生物的存在。 To accomplish microbial control, Municipal Water Authorities add disinfectants to drinking wat