公用工程质量标准.doc

物料名称 name氮气nitrogen标准ReferenceEP6.0USP31 企控氮 01/2008:1247NITROGEN低氧氮01/2008:1685NITROGEN, LOW-OXYGEN97% 氮Nitrogen 97 Percent氮 【7727-37-9】Nitrogen 7727-37-9.鉴别Identification首选鉴别：A。First identification: A.首选鉴别：AFirst identification: A.将燃烧的木头碎片插入充满97%氮气检测管时，火焰熄灭The flame of a burning wood splinter is extinguished when inserted into a test tube filled with Nitrogen 97 Percent当插入充满氮气检测管时，燃烧的木头碎片火焰熄灭The flame of a burning wood splinter is extinguished when inserted into a test tube filled with Nitrogen.气味(性质)Odor（CHARACTERS）为无色，无味气体。在20与101kPa压力下，一体积能溶解于约62体积的水和约10体积的乙醇A colourless, odourless gas. At 20 C and at a pressure of101 kPa, 1 volume dissolves in about 62 volumes of waterand about 10 volumes of alcohol.无色无味气体。溶解性：在20与101kPa压力下，一体积能溶解于约62体积的水和约10体积的乙醇。Colourless and odourless gas.Solubility : at 20 C and at a pressure of 101 kPa, 1 volumedissolves in about 62 volumes of water and about 10 volumesof alcohol.小心打开容器阀门产生一个适宜的气流。不要直接将气流对准脸，但使一部分气流对准鼻：分辨不出气味。Carefully open the container valve to produce a moderate flow of gas. Do not direct the gas stream toward the face, but deflect a portion of the stream toward the nose: no appreciable odor is discernible.小心打开容器阀门产生一个适宜的气流。不要将气流直接对准脸，但使一部分气流对准鼻：没有辨别出气味。Carefully open the container valve to produce a moderate flow of gas. Do not direct the gas stream toward the face, but deflect a portion of the stream toward the nose: no appreciable odor is discernible.二氧化碳Carbon dioxide不超过300ppm V/VNotmore than 300 ppmV/V, determined using a carbon dioxide detector tube (2.1.6).不超过0.03%not more than 0.03%.一氧化碳Carbon monoxide.不超过5ppm V/VNot more than 5 ppm V/V, determined using a carbon monoxide detector tube (2.1.6).不超过0.001%not more than 0.001%小于0.001%not more than 0.001%.二氧化硫Sulfur dioxide不超过5ppmnot more than 5 ppm氧化一氮和二氧化氮Limit of nitric oxide and nitrogen dioxide不超过2.5ppmnot more than 2.5 ppm氧气限度Limit of oxygen不超过50ppm V/VNotmore than 50 ppm V/V不超过3.0%Not more than 1.0% of oxygen不超过1.0%Not more than 1.0% of oxygen含量Assay不少于99.5%V/V的N2Nitrogen contains not less than 99.5 per cent V/V of N2最少含有99.5% V/V 的N2: minimum 99.5 per cent V/V of N2, calculated bydeduction of the sum of impurities found when performingthe test for impurities.N2含量以体积计不低于97.0%It contains not less than 97.0 percent, by volume, of N2.不低于99.0%Nitrogen contains not less than 99.0 percent, by volume, of N水蒸汽Water vapour不超过67ppm V/VNot more than 67 ppm V/V杂质IMPURITIESA， 氧；B 氬A. oxygen,B. argon包装与储存：Packaging and storage以压缩气体或液体方式，使用符合法规要求的适宜的容器来储存。Store as a compressed gas or a liquid in appropriatecontainers complying with the legal regulations.当氮气必须储存时，以压缩气体或液体的方式，储存于符合法规要求的适宜容器中。Where the gas has to be stored, store as a compressed gasor a liquid in appropriate containers complying with the legal regulations.保存于气瓶或低压收集储罐中Preserve in cylinders or in a low-pressure collecting tank.气瓶中储存Preserve in cylinders粒子particles微生物microbiological limit 第11页/共11页名称name压缩空气（药用空气）Medical Air 标准ReferenceEP6.0USP31企控EP6.0 01/2008:1238药用空气AIR, MEDICINAL01/2008:1684药用合成空气AIR, SYNTHETIC MEDICINALUSP31NF26 Page 1309Medical Air 定义DEFINITION压缩空气Compressed ambient air.氮（1247）与氧（0417）的混合气体Mixture of Nitrogen (1247) and Oxygen (0417).Medical Air is a natural or synthetic mixture of gases consisting largely of nitrogen and oxygen.药用空气药用空气是天然的或合成的含大部分氮与氧的混合气体性状CHARACTERS 气味 Odor无色、无味气体；溶解性：20C，压力101 kPa，1体积溶解于约50体积的水A colourless, odourless gas.Solubility: at a temperature of 20 C and a pressure of101 kPa, 1 volume dissolves in about 50 volumes of water.无色无味气体；溶解性：20C，压力101 kPa，1体积溶解于约50体积的水Colourless and odourless gas.Solubility: at a temperature of 20 C and a pressure of101 kPa, 1 volume dissolves in about 50 volumes of water.-小心开启容器阀门产生一个适宜的气流。不要直接将气流对准脸，但使一部分气流对准鼻：分辨不出气味Carefully open the container valve to produce a moderate flow of gas. Do not direct the gas stream toward the face, but deflect a portion of the stream toward the nose: no appreciable odor is discernible鉴别identification首选鉴别：CFirst identification: C.水和油Water and oil油：不超过0.1mg/m3Oil: maximum0.1mg/m3, determined using an oil detectortube (2.1.6).符合Conformance二氧化碳Carbon dioxide 不超过500 ppm V/V,maximum 500 ppm V/V, determined usinga carbon dioxide detector tube (2.1.6).不超过0.05%not more than 0.05%.一氧化碳Carbon monoxide 不超过5 ppmV/V,maximum5 ppmV/V, determined usinga carbon monoxide detector tube (2.1.6).不超过0.001%not more than 0.001%.氧化一氮和二氧化氮限度Limit of nitric oxide and nitrogen dioxide 不超过2 ppm V/V,maximum2 ppm V/V, determined using a nitrogen monoxide andnitrogen dioxide detector tube (2.1.6). 不超过2.5ppmnot more than 2.5 ppm.二氧化硫Sulfur dioxide 不超过1 ppm V/Vmaximum 1 ppm V/V, determined using asulphur dioxide detector tube (2.1.6).不超过5ppmnot more than 5 ppm.水蒸汽Water vapour : 不超过67 ppm V/V，maximum 67 ppm V/V, determined usinga water vapour detector tube (2.1.6), 不超过870 ppm V/V,（压力不超过10 bars，温度不低于5 Cexcept where thecompetent authority decides that the following limit appliesto medicinal air generated on-site and distributed in pipe-line systems operating at a pressure not greater than 10 bars and a temperature not less than 5 C: maximum 870 ppm V/V, determined using a water vapour detector tube (2.1.6).不超过67 ppm V/V.maximum67 ppmV/V, determined using awater vapour detector tube (2.1.6).杂质IMPURITIESA，二氧化碳B,二氧化硫C、一氧化氮D、二氧化氮E、油F、一氧化碳G、水A. carbon dioxide,B. sulphur dioxide,C. nitrogen monoxide,D. nitrogen dioxide,E. oil,F. carbon monoxide,G. water.A、水A. water.Assay氧含量Content of O2.含量：含氧为20.4%21.4% V/VContent : 20.4 per cent V/V to 21.4 per cent V/V ofoxygen (O2).含量：95.0%105.0%名义值，氧含量 21.0%22.5% V/V (O2).Content : 95.0 per cent to 105.0 per cent of the nominal value which is between 21.0 per cent V/V to 22.5 per cent V/V of oxygen (O2).（2.5.27）含有O2（以体积计）不少于19.5%并且不多于23.5%It contains not less than 19.5 percent and not more than 23.5 percent, by volume, of O2.包装与存储- Packaging and storage储存于适当的符合法规要求的容器的气体或者通过管线供应的气体As a gas, in suitable containers complying with the legalregulations or as a gas supplied by a pipe network.储存于适当的符合法规要求的容器的压缩气体或者通过管线供应的各组份混合后的压缩气体As a compressed gas in suitable containers complying with the legal regulations or as a compressed gas supplied by a pipe network, after mixing of the components.保存于气瓶或低压收集储罐中Preserve in cylinders or in a low pressure collecting tank. Containers used for Medical Air are not to be treated with any toxic, sleep-inducing, or narcosis-producing compounds, and are not to be treated with any compound that would be irritating to the respiratory tract when the Medical Air is used.粒子particles微生物microbiological limit标准EP USP31NF26 Page 3525Pharmacopeial Forum : Volume No. 31(2) Page 467 Pure Steam 纯蒸汽企控定义DinifinitionPure Steam is water that has been heated above 100 and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application.纯蒸汽是将水加热至100以上，并以防止源水被夹带的方式使之气化所得到。使用符合美国环境保护属基本饮用水标准、或欧联盟饮用水法规、或日本、世界卫生组织指南，不含其他添加物质。蒸汽饱和或干燥的程度、非冷凝气体的量，取决于纯蒸汽的使用。Bacterial endotoxins 85细菌内毒素85The condensate contains less than 0.25 USP Endotoxin Unit per mL (when used in the production of parenterals). 其冷凝水含内毒素应小于0.25 USP EU/ml（用于非肠道给药制品）Total organic carbon 643总有