haohanPorapak Q口服液体药用聚酯瓶YBB00102002-2015乙醛测定填充柱

浩瀚色谱（山东）应用技术开发有限公司分析药用聚酯（PET）瓶中乙醛测定法现状,并对其进行标准提高。方法:采用优化后的HS-GC法测定药用PET瓶中乙醛残留量。顶空平衡温度40℃,定量环温度50℃,传输线温度60℃,对照品顶空平衡时间30 min,样品顶空平衡时间8 h,进样体积1 m L;色谱柱PORAPAK Q（2M*3MM）,柱温50℃,进样口温度200℃,检测器温度250℃,载气氮气,柱流量1.5 m L·min^-1,分流比30∶1。结果:采用优化后的乙醛测定方法,乙醛对照品进样量在0.2～3.0μg范围内呈良好线性关系,r=0.999 6;高、中、低加样回收率分别为98.6%、106.3%和100.4%。优化前后乙醛测定法测得乙醛含量结果无显著性差异。结论:优化提高后的乙醛测定法能快速、准确地测定药用PET瓶中乙醛含量,该研究为乙醛测定法的标准提高以及药用PET瓶的质量控制提供指导意义。 

名称：填充柱
固定相：乙基乙烯苯-二乙烯苯共聚物
规格：2m*3mm
型号：Porapak Q
粒度：60-80目
应用：YBB00102002-2015口服液体药用聚酯瓶
YBB00102002 口服液体药用聚酯瓶（试行）
 

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. analyzed the current status of acetaldehyde determination methods in pharmaceutical polyester (PET) bottles, and improved its standards. Methods: The optimized HS-GC method was used to determine the acetaldehyde residues in pharmaceutical PET bottles. The headspace equilibrium temperature was 40 °C, the loop temperature was 50 °C, the transfer line temperature was 60 °C, the headspace equilibrium time of the reference substance was 30 min, the sample headspace equilibrium time was 8 h, and the injection volume was 1 mL; the chromatographic column PORAPAK Q (2M*3MM) ), the column temperature was 50 °C, the inlet temperature was 200 °C, the detector temperature was 250 °C, the carrier gas was nitrogen, the column flow rate was 1.5 mL·min-1, and the split ratio was 30:1. RESULTS: Using the optimized acetaldehyde determination method, the injection amount of acetaldehyde reference substance showed a good linear relationship in the range of 0.2-3.0 μg, r=0.999 6; the high, medium and low sample recovery rates were 98.6% and 106.3 respectively. % and 100.4%. There was no significant difference in the acetaldehyde content measured by the acetaldehyde determination method before and after the optimization. Conclusion: The optimized and improved acetaldehyde determination method can quickly and accurately determine the content of acetaldehyde in pharmaceutical PET bottles. 

Name: Packed Column
Stationary Phase: Ethylvinylbenzene-divinylbenzene copolymer
Specifications: 2m*3mm
Model: Porapak Q
Granularity: 60-80 mesh
Application: YBB00102002-2015 Oral liquid medicinal polyester bottle
YBB00102002 Oral liquid medicinal polyester bottle (trial)