名稱：毛細管柱

固定相：聚乙二醇

規(guī)格：30m*0.25mm*0.25um

型號：HH-WAX

應用：頂空氣相色譜法測定藥品中環(huán)氧氯丙烷溶劑殘留

目前，在國內(nèi)以左奧硝唑為活性成分上市銷售的制劑左奧硝唑氯化鈉注射液，該藥屬硝基咪唑衍生物類抗厭氧菌藥，為奧硝唑的左旋體。臨床試驗結果表明，左奧硝唑氯化鈉注射液與奧硝唑氯化鈉注射液相比，在減少頭暈、嗜睡不良反應發(fā)生率方面，具有臨床統(tǒng)計學意義。

環(huán)氧丙烷為合成左奧硝唑的起始原料s-環(huán)氧氯丙烷中的工藝雜質(zhì)，環(huán)氧丙烷為國際癌癥研究所(iarc)列為人類可疑致癌化學物，其具有致基因突變的警示結構，ichm7分類為1類基因毒性雜質(zhì)，因此，能夠檢測左奧硝唑氯化鈉注射液中活性成分中殘留環(huán)氧丙烷的方法對于控制臨床用藥的安全性具有非常重要的意義。

浩瀚色譜（山東）應用技術開發(fā)有限公司研發(fā)一種藥物中殘留環(huán)氧丙烷的檢測方法，所述的檢測方法采用頂空氣相色譜法，藥物的稀釋劑為N,N?二甲基甲酰胺。采用該檢測方法可以有效地檢測藥物例如奧硝唑、或左奧硝唑中可能存在環(huán)氧丙烷的殘留情況。

Capillary Column for Detection of Residual Propylene Oxide in Drugs
Capillary column for the detection of residual propylene oxide in pharmaceuticals Details:

Name: capillary column

Stationary Phase: Polyethylene Glycol

Specifications: 30m*0.25mm*0.25um

Model: HH-WAX

Application: Determination of Epichlorohydrin Solvent Residues in Drugs by Headspace Gas Chromatography

At present, only levornidazole sodium chloride injection is the only preparation marketed in China with levornidazole as the active ingredient, which is a nitroimidazole derivative anti-anaerobic bacteria drug and is the levorotatory form of ornidazole. The clinical trial results showed that compared with ornidazole sodium chloride injection, levoornidazole sodium chloride injection has clinical statistical significance in reducing the incidence of dizziness and drowsiness.

Propylene oxide is a process impurity in s-epichlorohydrin, the starting material for synthesizing levornidazole. Propylene oxide is listed as a suspected carcinogen by the International Institute for Cancer Research (iarc), and it has a warning of gene mutation. structure, ichm7 is classified as a class 1 genotoxic impurity, therefore, a method capable of detecting residual propylene oxide in the active ingredient in levornidazole sodium chloride injection is of great significance for controlling the safety of clinical medication.

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has developed a detection method for residual propylene oxide in drugs. The detection method adopts headspace gas chromatography, and the diluent of the drug is N,N-dimethylformamide. The detection method can effectively detect the possible residual situation of propylene oxide in drugs such as ornidazole or levoornidazole.



Capillary column for detection of residual propylene oxide in pharmaceuticals Test chromatogram: