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建立和验证一种方法,以确定埃诺沙巴林的抗Xa因子强度

En Zhang^1,2, Hanyan Zou^1,2, Yandong Dong^1,2

¹Chongqing Institute for Food and Drug Control, Chongqing, China.

|May 12, 2025

概括

一种新的方法来确定埃诺沙巴林.

科学领域:

药品分析药品分析
生物技术是生物技术.
药理学药理学是指药理学的学科.

背景情况:

埃诺沙巴林是一种广泛使用的抗凝剂.
准确确定其抗Xa因子功效对于质量控制至关重要.
现有的方法可能昂贵或低效.

研究的目的:

建立和验证一种高效,可靠和易于使用的方法来确定氧沙抗Xa因子功效.
确保遵守国际和中国药典标准.
为传统方法提供一个具有成本效益的替代方案.

主要方法:

方法验证包括特异性,线性,精度,准确性和稳定性.
与欧洲药典的方法进行比较.
评估样品和试剂消耗,成本和运营效率.

主要成果:

该方法表现出极好的特异性,线性 (0.054-0.192 IU/mL),精度,准确性 (98.0%-102.0%回收率) 和稳定性.
结果显示高可重复性 (在2.0%RSD范围内) 和与欧洲药典一致.
该方法符合ICH指南和中国药典的要求.

结论:

经过验证的方法是有效的,可靠的,和用户友好的氧沙抗Xa因子强度的确定.
它在降低成本和优化运营方面提供了显著的优势.
为氧沙生产和质量监测提供必要的技术支持.

关键词:

抗Xa因子抗Xa因子伊诺克萨帕林酸盐方法验证方法的验证方法.强度的确定强度的确定.质量控制质量控制

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