拟议的一项限制测试,检测帕拉塞他制药配方中的p-chloroaniline杂质
Naif Aljuhani1, Ibrahim A Al Othaim2, Nehad A Abdallah3
1Pharmacology and Toxicology Department, College of Pharmacy, Taibah University, 30078, Al- Madinah Al-Mounawarah, KSA, Saudi Arabia.
Scientific reports
|November 11, 2025
概括
一种新的液态染色体质谱法 (LC/MS) 方法检测了中有害杂质P-chloroaniline. 这种经过验证的方法通过控制药品中的污染物来确保药品质量和患者安全.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 环境化学环境化学
背景情况:
- P-chloroaniline 是一种在药品中发现的有毒的有机化合物.
- 目前,该杂质在青的活性药物成分 (API) 或成品中没有受到控制.
- 人们担心帕拉塞他配方中的P-chloroaniline污染.
研究的目的:
- 开发和验证一种敏感和选择性的LC/MS方法来确定P-chloroaniline.
- 应用该方法作为对帕拉塞他制药配方中的P-chloroaniline的极限测试.
- 通过对污染物进行控制,确保帕拉塞他产品的质量和患者的安全.
主要方法:
- 液态色谱分离使用35°C的C18柱.
- 电子喷射电离 (ESI) 质谱仪用于离子监测.
- 根据ICH Q2 (R1) 准则的方法验证作为极限测试.
主要成果:
- 开发的LC/MS方法显示出高灵敏度和特异性.
- 该方法成功确定了P-chloroaniline在11种偏醇制药配方中的含量.
- 验证证实了该方法适用于检测P-chloroaniline污染的适用性.
结论:
- 经过验证的LC/MS方法提供了一种可靠的策略,用于检测中P-chloroaniline.
- 实施这种方法可以确保药品符合质量标准.
- 这有助于通过控制有害杂质来提高患者的安全性.
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