一种GC-MS方法用于确定无活化Covid-19疫苗中的β-propiolactone残留物
Seyedeh Zohreh Mirjalili1, Zahra Tamiji1,2, Mehrnoosh Shirangi1
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Engelab Ave, Tehran 14155-6451, Iran.
Journal of chromatographic science
|September 17, 2024
概括
一种新的气体染色体质谱法准确量化了COVID-19疫苗中的残留β-propiolactone. 这确保了疫苗的安全性,确认了致癌性失活剂的不存在.
科学领域:
- 分析化学 分析化学
- 疫苗学 疫苗学 疫苗学
背景情况:
- β-propiolactone 是一种常见的疫苗失活剂.
- 它的致癌性需要完全水解以防止细胞毒性.
- 准确测量残留β-propiolactone对于疫苗安全至关重要.
研究的目的:
- 开发一种简单,快速和准确的方法来量化在非活化COVID-19疫苗中的残留β-propiolactone.
- 通过检测微量β-propiolactone来确保非活化疫苗的安全性和质量.
主要方法:
- 气色谱-质谱法 (GC-MS) 用于分析.
- 乙烯酸乙烯被用于从疫苗介质中提取分析物.
- 卡普罗拉克作为量化的内部标准.
主要成果:
- 开发的GC-MS方法在0.2-20μg/mL范围内显示出出色的线性 (r2>0.99).
- 检测极限为0.07微克/毫升,量化极限为0.20微克/毫升.
- 在测试的非活化COVID-19疫苗样本中没有检测到β-propiolactone.
结论:
- 已建立的GC-MS方法适用于非活化COVID-19疫苗的可靠质量控制.
- 没有可检测的β-propiolactone证实了测试疫苗样本的合格性.
- 这种分析方法有助于确保无活化疫苗的安全性.
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