辅助剂中酸盐的测试 - - 行业最佳实践
Sebastian Hickert1, Kevin Näf2, Jinjian Zheng3
1Merck KGaA, Darmstadt, Germany.
概括
通过检测辅助剂中的酸盐来管理制药中的酸胺风险. 这项研究评估了分析方法,如IC,Griess,DAN和循环酸盐衍生,以准确量化酸盐,帮助风险评估.
科学领域:
- 制药分析 制药分析
- 分析化学是一种分析化学.
- 药物安全 药物安全
背景情况:
- 药品辅助剂中的酸盐可以与氨基发生反应,形成潜在的致癌性N-酸胺.
- 准确检测和量化酸盐对于N-尼托胺风险评估和减轻药物开发中的风险至关重要.
- 建立了一个行业联盟和数据库,以应对亚酸盐分析的挑战.
研究的目的:
- 审查和演示用于量化药品辅助剂中酸盐的分析技术.
- 在行业合作伙伴之间分享知识和最佳实践.
- 为了方便选择合适的酸盐测定分析方法.
主要方法:
- 离子色谱 (IC) 具有导电性或紫外线检测.
- 灰色衍生,其次是HPLC-UV或MS/MS检测,或在IC之后作为后列衍生 (PCD).
- 用光 (FL) 和质谱法 (MS) 检测的2,3-氨甲 (DAN) 衍生物化.
- 循环酸盐衍生物化与气色谱-火焰电离检测 (GC-FID) 或GC-MS检测.
主要成果:
- 该研究详细介绍了各种分析技术的原理,性能特征和样本准备.
- 使用联盟数据揭示了酸盐的一系列可实现量化极限 (LOQs).
- 确定了每个分析技术的优点和缺点.
结论:
- 存在各种验证的分析方法,用于辅助剂中酸盐的量化.
- 了解每个技术的性能和局限性对于有效的N-尼托胺风险管理至关重要.
- 这项工作支持药品质量控制分析方法的明智选择.
相关概念视频
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Secondary amines react with nitrous acid to form N-nitrosamines, as depicted in Figure 1. Nitrous acid, a weak and unstable acid, is formed in situ from an aqueous solution of sodium nitrite and strong acids, such as hydrochloric acid or sulfuric acid, in cold conditions. In the presence of an acid, the nitrous acid gets protonated. The subsequent loss of water results in the formation of the electrophile known as nitrosonium ion.
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