浩瀚色譜（山東）應(yīng)用技術(shù)開發(fā)有限公司分析藥用聚酯(PET)瓶中乙醛測(cè)定法現(xiàn)狀,并對(duì)其進(jìn)行標(biāo)準(zhǔn)提高.方法:采用優(yōu)化后的HS-GC法測(cè)定藥用PET瓶中乙醛殘留量.頂空平衡溫度40℃,定量環(huán)溫度50℃,傳輸線溫度60℃,對(duì)照品頂空平衡時(shí)間30 min,樣品頂空平衡時(shí)間8 h,進(jìn)樣體積1 m L;色譜柱PQ,柱溫130℃,進(jìn)樣口溫度200℃,檢測(cè)器溫度250℃,載氣氮?dú)?柱流量1.5 m L·min^(-1),分流比30:1.結(jié)果:采用優(yōu)化后的乙醛測(cè)定方法,乙醛對(duì)照品進(jìn)樣量在0.2~3.0μg范圍內(nèi)呈良好線性關(guān)系,r=0.9996;高,中,低加樣回收率分別為98.6%,106.3%和100.4%.優(yōu)化前后乙醛測(cè)定法測(cè)得乙醛含量結(jié)果無顯著性差異.結(jié)論:優(yōu)化提高后的乙醛測(cè)定法能快速,準(zhǔn)確地測(cè)定藥用PET瓶中乙醛含量,該研究為乙醛測(cè)定法的標(biāo)準(zhǔn)提高以及藥用PET瓶的質(zhì)量控制提供指導(dǎo)意義.

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Porapak Q填充柱測(cè)定口服液聚酯瓶中乙醛  測(cè)試譜圖：



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: