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Updated: Sep 19, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s
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药品中的突变性杂质的风险评估,检测和控制:重点是氨酸胺

Aishwarya Dande1, H M Chandra Mouli2, Joshita Nandy1

  • 1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, Bihar 844102, India.

Critical reviews in analytical chemistry
|June 17, 2025
PubMed
概括

氨酸胺等致变异性杂质构成风险,目前的检测和控制方法往往不足. 综合化学见解,先进分析和体内研究的综合方法对于药品安全和监管合规至关重要.

关键词:
降解产品是一种降解产品.遗传毒性 遗传毒性 遗传毒性突变性 突变性 突变性尼托胺是一种氨酸.风险评估 风险评估 风险评估

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