发布时间 : 星期二 文章USP34 645 水的电导率(中英文)更新完毕开始阅读
6.3 6.4 6.5 6.6 6.7 6.8 6.9 7.0 STERILE WATER 无菌用水 2.4 2.3 2.2 2.1 2.6 3.1 3.8 4.6 The procedure and test limits are intended for Sterile Purified Water, Sterile Water for Injection, Sterile Water for Inhalation, and Sterile Water for Irrigation, and any other monographs which specify this section. 本检测程序和检测限度适用于无菌纯化水，注射用无菌水，吸入剂用无菌水，冲洗剂用无菌水以及其它引用本部分的各论。 The sterile waters are derived from Purified Water or Water for Injection, and therefore have been determined to be compliant with the Bulk Water requirements before being stored in the container. The specification provided represents the maximum allowable conductivity value, taking into consideration the limitation of the measurement method and reasonable container leaching. Such specification and the sampling volume choices should be defined and validated on the basis of the intended purpose of the water. 无菌水是从纯化水或注射用水中制取的，因此在存贮至容器中之前应符合散装水的要求。考虑至测量方法的局限性及合理的容器渗出，所提出的质量标准代表了最大允许电导率值。该质量标准和样品量的选择应界定并基于水的用途进行验证。 Procedure 程序 Transfer a sufficient amount of water to a suitable container, and stir the test specimen. Adjust the temperature, if necessary, and, while maintaining it at 25 ± 1℃ , begin vigorously agitating the test specimen while periodically observing the conductivity. When the change in conductivity (due to uptake of ambient carbon dioxide) is less than a net of 0.1 μS/cm per 5 minutes, note the conductivity. 取足够数量水样于适当容器中，搅拌，调节温度并保持25 ± 1℃，剧烈搅拌样品，周期检测样品电导率，直至5分钟内变化值小于0.1μS/cm，记录电导率。 For containers with a nominal volume of 10 mL or less, if the conductivity is not greater than 25 μS/cm, the water meets the requirements. For containers with a nominal volume greater than 10 mL, if the conductivity is not greater than 5 μS/cm, the water meets the requirements. 对于标示体积为10ml及更小的容器，如果电导率不大于25μS/cm，则水样符合要求。对于标示体积大于10ml的容器，如果电导率不大于5 μS/cm，则水样符合要求。
Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee (GCCA2010) General Chapter-Chemical Analysis General Chapter Antonio Hemandez-Cardoso.M.Sc Senior Scientific Liaison 1-301-816-8308 USP34–NF29 Page 252 Pharmacopeial Forum: Volume No. 35(5) Page 1226