2m*6mm Porapak Q填充柱测定口服液聚酯瓶中乙醛

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PQ,柱温130℃,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=0.9996;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.

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Porapak Q填充柱测定口服液聚酯瓶中乙醛  测试谱图：



Determination of Acetaldehyde in Oral Liquid PET Bottle with Porapak Q Packed Column
Determination of Acetaldehyde in Oral Liquid PET Bottle with Porapak Q Packed Column Details:

Name: Packed Column
Stationary Phase: Ethylvinylbenzene-divinylbenzene copolymer
Specifications: 2m*6mm
Model: Porapak Q or GDX-102 (80-100 mesh)
Granularity: 80-100 mesh
Application: YBB00102002 Oral liquid medicinal polyester bottle (trial)

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. analyzed the current situation of the determination method of acetaldehyde in pharmaceutical polyester (PET) bottles, and improved its standards. Methods: The optimized HS-GC method was used to determine the acetaldehyde in pharmaceutical PET bottles. Aldehyde residue. 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 column PQ, The column temperature was 130°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: The optimized acetaldehyde was used for the determination Method, the injection volume of acetaldehyde reference substance showed a good linear relationship in the range of 0.2~3.0 μg, r=0.9996; the high, medium and low sample recovery rates were 98.6%, 106.3% and 100.4%, respectively. Determination of acetaldehyde before and after optimization There was no significant difference in the results of the acetaldehyde content measured by the method. Conclusion: The optimized and improved acetaldehyde determination method can quickly and accurately determine the acetaldehyde content in pharmaceutical PET bottles. The quality control of PET bottles provides guidance.

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Determination of acetaldehyde in oral liquid polyester bottle with Porapak Q packed column Test chromatogram: