一个头部空间GC-MS方法来量化药物产品中胺杂物和前体:方法验证和产品测试
Susan Daniela Selaya1,2, Nicolas Abrigo1,2, Dustin G Brown1
1Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.
Biomedical chromatography : BMC
|November 7, 2024
概括
一种新的Headspace GC-MS方法可以检测药品中的NDMA等尼托胺杂质. 这种经过验证的方法有助于制造商减轻药品中的这些有害污染物.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 亚胺杂质在制药产品中构成重大风险.
- 监管机构要求严格控制这些污染物.
研究的目的:
- 开发和验证一个Headspace GC-MS方法来检测胺杂物.
- 量化N-二甲基胺 (NDMA),N-二甲基胺 (NDEA),N-二二胺 (NDIPA) 和N-二甲基胺 (NEIPA) 的含量.
- 包括二甲基形式胺 (DMF) 分析,因为它有可能形成NDMA前体.
主要方法:
- 使用了头部空间气体染色学和质谱学 (GC-MS).
- 方法验证是按照ICH Q2的指导方针进行的.
- 该程序适用于分析NDMA前体.
主要成果:
- 该方法成功地检测和量化了药物产品中的胺.
- 在萨尔坦药物产品中发现的NDMA含量在0.1至113ppm之间.
- 该方法用于研究在甲胺中罗斯胺缓解策略.
结论:
- 对于检测尼托胺杂质,有一种经过验证的分析方法可用.
- 这种方法支持制药厂商确保药物产品安全.
- 这些发现有助于控制制药中的尼托胺污染.
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