Porapak Q 填充柱测定乙醛残留 YBB00102002 口服液体药用聚酯瓶(试行)

本标准适用于以聚对苯二甲酸乙二醇酯（ PET） 为主要原料 ，采用注吹成型工艺生产的口服液体制剂用塑料瓶 。

【 乙醛】 照乙醛测定法 （ YBB00282004-2015 ） 第yi法测定，不得过千万分之二 。

浩瀚色谱（山东）应用技术开发有限公司建立口服液体药用聚酯瓶中乙醛残留量的测定方法。方法:采用顶空气相色谱法。色谱柱为Porapak Q填充柱,氢火焰离子化检测器,进样口温度为200℃,检测器温度为200℃,载气为氮气;顶空进样器平衡温度为70℃,平衡时间为30min,程序升温。结果:乙醛检测浓度线性范围为0.002～0.02mg·L-（1r=0.9991）,平均回收率为98.37%,RSD=2.82%（n=6）,检测限为0.1ng。结论:本方法准确,可用于口服液体药用聚酯瓶中乙醛的限度检查。 


YBB00102002 口服液体药用聚酯瓶(试行)  测试谱图：



YBB00102002 Oral liquid medicinal polyester bottle (trial)
YBB00102002 Oral liquid medicinal polyester bottle (trial) Details:

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)
This standard applies to plastic bottles for oral liquid preparations produced by injection blow molding with polyethylene terephthalate (PET) as the main raw material.

【Acetaldehyde】According to the acetaldehyde determination method (YBB00282004-2015) yi method, it should not exceed 2/10 million.

Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a method for the determination of acetaldehyde residues in oral liquid pharmaceutical polyester bottles. Methods: Headspace gas chromatography was used. The chromatographic column was a Porapak Q packed column, a hydrogen flame ionization detector, the inlet temperature was 200 °C, the detector temperature was 200 °C, and the carrier gas was nitrogen; the equilibrium temperature of the headspace sampler was 70 °C, and the equilibration time was 30 min. , Program temperature. Results: The linear range of acetaldehyde concentration was 0.002～0.02mg·L-(1r=0.9991), the average recovery was 98.37%, RSD=2.82% (n=6), and the detection limit was 0.1ng. CONCLUSION: This method is accurate and reliable, and can be used for the limit inspection of acetaldehyde in oral liquid pharmaceutical polyester bottles.


YBB00102002 Oral liquid medicinal polyester bottle (trial) Test spectrum: