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Updated: Jul 9, 2026

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分析程序开发和拟定条件:基于质谱学的NDSRI分析程序的案例研究

Jinhui Zhang1, Ramesh Raghavachari2, Douglas C Kirkpatrick3

  • 1Division of Product Quality Research, Office of Testing and Research, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.

Journal of pharmaceutical sciences
|August 7, 2024
PubMed
概括

本研究展示了应用增强的分析程序开发和生命周期管理原则,包括设计后的分析质量 (AQbD),以创建一个胺杂质方法. 它详细说明了为更好的药物物质分析建立条件和报告类别的细节.

关键词:
分析目标配置文件的分析.确定的条件 确定的条件知识管理知识管理质谱测量质量谱测量NDSRI (尼胺药物物质相关的杂质)风险评估 风险评估 风险评估

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