北京2020藥典二氧化碳凈化裝置
北京2020藥典二氧化碳凈化裝置 詳細信息:
名稱:藥典二氧化碳(CO2)凈化裝置
型號:HHO-III Purification device
應用:2020版中國藥典二氧化碳中碳氫化合物測定 氣相色譜法
2020年版《中國藥典》共收載品種5911種,其中,新增319種,修訂3177種,不再收載10種,品種調整合并4種。一部中藥收載2711種,其中新增117種、修訂452種。二部化學藥收載2712種,其中新增117種、修訂2387種。三部生物制品收載153種,其中新增2種、修訂126種;新增生物制品通則2個、總論4個。四部收載通用技術要求361個,其中制劑通則38個(修訂35個)、檢測方法及其他通則281個(新增35個、修訂51個)、指導原則42個(新增12個、修訂12個);藥用輔料收載335種,其中新增65種、修訂212種。
作為我國藥品質量的法典,本版藥典在保持科學性、先進性、規范性和權威性的基礎上,著力解決制約藥品質量與安全的突出問題,著力提高藥品標準質量控制水平,充分借鑒了國際先進技術和經驗,客觀反映了中國當前醫藥工業、臨床用藥及檢驗技術的水平,必將在提高藥品質量過程中起到積極而重要的作用,并將進一步擴大和提升我國藥典在國際上的積極影響。
碳氫化合物照氣相色譜法(通則0521)測定供試品氣體取本品,即得對照品氣體取甲烷含量為0.0020%的氣體(以氮氣為稀釋劑)。色譜條件用玻璃球為填料的色譜柱(4mm×0.8m,80目);柱溫為110℃;進樣口溫度為110℃;檢測器為火焰離子化檢測器,溫度為120℃測定法精密量取供試品氣體與對照品氣體,分別注入氣相色譜儀,在凈化溫度為360℃時測得的峰面積為相應空白值;精密量取供試品氣體與對照品氣體,分別注入氣相色譜儀,測定峰面積,減去相應空白值后的峰面積為校正峰面積限度按外標法以校正峰面積計算,含碳氫化合物(以甲烷計)不得過0.0020%。
浩瀚色譜(山東)應用技術開發有限公司,采用新技術新方案,依據2020版藥典二氧化碳的指標控制要求,研制生產HHO-III Purification device二氧化碳凈化裝置,完全滿足藥典二氧化碳2020版的要求,在國內外眾多制藥企業使用,效果良好,凈化徹底,在安捷倫,島津,賽默飛,瓦里安,布魯克等氣相色譜儀上安裝測試,受用戶好評。
北京2020藥典二氧化碳凈化裝置 測試譜圖:









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 co
ntains a total of 5,911 varieties, of which 319 are newly added, 3177 are revised, 10 are no lo
nger included, and 4 varieties have been adjusted and merged. A piece of traditio
nal Chinese medicine co
ntains 2,711 kinds, of which 117 kinds are newly added and 452 kinds are revised. The two chemical medicines co
ntained 2,712 kinds, of which 117 kinds were newly added and 2387 kinds were revised. The three biological products co
ntained 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 co
ntain 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 co
ntrol level of medicines. Internatio
nal 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 im
portant role in improving the quality of medicines, and will further expand and enhance the internatio
nal 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 co
ntent of 0.0020% (with nitrogen as a diluent). Chromatographic co
nditions 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 io
nization 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 correspo
nding 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 correspo
nding blank value is the calibrated peak area limit. The peak area is calculated by the external standard method, and the hydrocarbon co
ntent (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 co
ntrol 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:
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