HHO-III Purification device 北京2020药典二氧化碳净化装置

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北京2020药典二氧化碳净化装置
北京2020药典二氧化碳净化装置 详细信息：

名称：药典二氧化碳（CO2）净化装置

型号：HHO-III Purification device

应用：2020版中国药典二氧化碳中碳氢化合物测定  气相色谱法

2020年版《中国药典》共收载品种5911种，其中，新增319种，修订3177种，不再收载10种，品种调整合并4种。一部中药收载2711种，其中新增117种、修订452种。二部化学药收载2712种，其中新增117种、修订2387种。三部生物制品收载153种，其中新增2种、修订126种；新增生物制品通则2个、总论4个。四部收载通用技术要求361个，其中制剂通则38个（修订35个）、检测方法及其他通则281个（新增35个、修订51个）、指导原则42个（新增12个、修订12个）；药用辅料收载335种，其中新增65种、修订212种。

作为我国药品质量的法典，本版药典在保持科学性、先进性、规范性和权威性的基础上，着力解决制约药品质量与安全的突出问题，着力提高药品标准质量控制水平，充分借鉴了国际先进技术和经验，客观反映了中国当前医药工业、临床用药及检验技术的水平，必将在提高药品质量过程中起到积极而重要的作用，并将进一步扩大和提升我国药典在国际上的积极影响。

碳氢化合物照气相色谱法(通则0521)测定供试品气体取本品,即得对照品气体取甲烷含量为0.0020%的气体(以氮气为稀释剂)。色谱条件用玻璃球为填料的色谱柱(4mm×0.8m,80目);柱温为110℃;进样口温度为110℃;检测器为火焰离子化检测器,温度为120℃测定法精密量取供试品气体与对照品气体,分别注入气相色谱仪,在净化温度为360℃时测得的峰面积为相应空白值;精密量取供试品气体与对照品气体,分别注入气相色谱仪,测定峰面积,减去相应空白值后的峰面积为校正峰面积限度按外标法以校正峰面积计算,含碳氢化合物(以甲烷计)不得过0.0020%。

浩瀚色谱（山东）应用技术开发有限公司，采用新技术新方案，依据2020版药典二氧化碳的指标控制要求，研制生产HHO-III Purification device二氧化碳净化装置，完全满足药典二氧化碳2020版的要求，在国内外众多制药企业使用，效果良好，净化彻底，在安捷伦，岛津，赛默飞，瓦里安，布鲁克等气相色谱仪上安装测试，受用户好评。


北京2020药典二氧化碳净化装置 测试谱图：



Beijing 2020 Pharmacopoeia carbon dioxide purification device
Beijing 2020 Pharmacopoeia Carbon Dioxide Purification Device Details:

Name: Pharmacopoeia carbon dioxide (CO2) purification device

Model: HHO-III Purification device

Application: 2020 Chinese Pharmacopoeia Determination of Hydrocarbons in Carbon Dioxide Gas Chromatography



The 2020 edition of the Chinese Pharmacopoeia contains a total of 5,911 varieties, of which 319 are newly added, 3177 are revised, 10 are no longer included, and 4 varieties have been adjusted and merged. A piece of traditional Chinese medicine contains 2,711 kinds, of which 117 kinds are newly added and 452 kinds are revised. The two chemical medicines contained 2,712 kinds, of which 117 kinds were newly added and 2387 kinds were revised. The three biological products contained 153 kinds, of which 2 were newly added and 126 were revised; 2 general rules of biological products and 4 general rules were newly added. The four parts contain 361 general technical requirements, including 38 general preparations (35 revisions), 281 testing methods and other general rules (35 new additions, 51 revisions), and 42 guiding principles (12 new additions, 12 revisions) A); 335 kinds of medicinal excipients were collected, of which 65 kinds were newly added and 212 kinds were revised.

As a code for ensuring the quality of medicines in my country, this edition of the pharmacopoeia, on the basis of maintaining scientific, advanced, standardized and authoritative, focuses on solving outstanding problems that restrict the quality and safety of medicines, and strives to improve the quality control level of medicines. International advanced technology and experience objectively reflect the current level of China’s pharmaceutical industry, clinical medication and testing technology, and will surely play an active and important role in improving the quality of medicines, and will further expand and enhance the international level of my country’s Pharmacopoeia. positive influence.

Hydrocarbons are determined according to gas chromatography (General Principle 0521). Take this product as the test sample gas, that is, the reference sample gas should be a gas with a methane content of 0.0020% (with nitrogen as a diluent). Chromatographic conditions use a chromatographic column filled with glass balls (4mm×0.8m, 80 mesh); the column temperature is 110℃; the temperature of the injection port is 110℃; the detector is a flame ionization detector, and the temperature is 120℃. The method is precise. Measure the test gas and reference gas and inject them into the gas chromatograph respectively. The peak area measured when the purification temperature is 360°C is the corresponding blank value; accurately measure the test gas and reference gas and inject them into the gas chromatograph. The peak area is determined by the instrument, and the peak area after subtracting the corresponding blank value is the calibrated peak area limit. The peak area is calculated by the external standard method, and the hydrocarbon content (calculated as methane) shall not exceed 0.0020%.

Haohan Chromatography (Shandong) Applied Technology Development Co., Ltd. adopts new technologies and researches new solutions, and develops and produces HHO-III Purification device carbon dioxide purification device according to the index control requirements of the 2020 edition of the pharmacopoeia, which fully meets the requirements of the 2020 edition of the pharmacopoeia. Used by many domestic and foreign pharmaceutical companies, the effect is good and the purification is thorough. It has been installed and tested on Agilent, Shimadzu, Thermo Fisher, Varian, Bruker and other gas chromatographs. It meets the requirements and is well received by users.


Beijing 2020 Pharmacopoeia carbon dioxide purification device test spectrum: