haohan吸入麻醉剂异氟烷中微量杂质测定毛细管柱HH-1

全身性吸入麻醉剂异氟烷(isoflurane,CF3CHCl-O-CHF2)具有不良反应小、易于控制麻醉深度等特点而在国内外临床上广泛使用。美国药典24版采用氢火焰离子化检测器(FID)程序升温气相色谱法测定杂质和含量。我国部颁标准采用电子捕获检测器(ECD)的气相色谱内标法测定挥发性杂质总量。

对异氟烷中杂质的定性分析未见报道,为严格控制产品中杂质量,进一步完善生产工艺,提高产品质量,浩瀚色谱（山东）应用技术开发有限公司采用GC-ECD,气质联用(GC-MS)法对异氟烷中杂质进行了定性分析,并对其中杂质进行了文献检索。

名称：毛细管柱
固定相：100%二甲基聚硅氧烷
规格：30m*0.32mm*1.0um
型号：HH-1
应用：气相色谱法测定异氟烷含量
Isoflurane (CF3CHCl-O-CHF2), a general inhalation anesthetic, is widely used in clinical practice at home and abroad because of its small adverse reactions and easy control of the depth of anesthesia. Impurities and contents were determined by temperature programmed gas chromatography with hydrogen flame ionization detector (FID) in USP 24. The internal standard method of gas chromatography with electron capture detector (ECD) is used to determine the total volatile impurities in the ministerial standard of China.



There is no report on the qualitative analysis of impurities in isoflurane. In order to strictly control the quality of impurities in the product, further improve the production process, and improve the product quality, Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. used GC-ECD and GC-MS to qualitatively analyze the impurities in isoflurane, and carried out a literature search for the impurities.



Name: capillary column

Stationary phase: 100% dimethylpolysiloxane

Specification: 30m * 0.32mm * 1.0um

Model: HH-1

Application: determination of isoflurane content by gas chromatography