基于质量平衡方法的分析方法,用于测环素化的纯度评估
Sunyoung Lee1, Song-Yee Baek1, Ha-Jeong Kwon1
1Division of Chemical and Biological Metrology, Korea Research Institute of Standards and Science (KRISS), Deajeon 34113, Republic of Korea.
Molecules (Basel, Switzerland)
|November 25, 2023
概括
分析方法使用质量平衡方法准确地确定了四环素化的纯度. 这确保了用于兽药药物分析的杂质的可靠量化,可追溯到国际单位.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 兽医医学 兽医医学 兽医医学
背景情况:
- 准确的纯度评估对于制药化合物至关重要,特别是在兽医应用中.
- 四环素化物是一种广泛使用的兽药,需要严格的质量控制.
- 现有的方法可能无法全面解决盐化合物的所有杂质概况.
研究的目的:
- 开发和验证使用质量平衡方法对四环素化的纯度评估的分析方法.
- 通过独立的分析技术量化单个杂质类别.
- 为了建立一个可追溯的纯度分配为四环素化自由和盐的形式.
主要方法:
- 质量平衡方法集成多种分析技术.
- 离子色谱-导电检测 (IC-CD) 对于含量.
- 液体色谱-紫外线检测 (LC-UV) 相关杂质.
- 卡尔·菲舍尔 (KF) 对含水量进行定位.
- 头空间气体染色学/质谱学 (HS-GC/MS) 用于残留溶剂.
- 对非挥发性物质进行热重力测量分析 (TGA).
- 定量核磁共振 (q-NMR) 用于直接纯度测定.
主要成果:
- 质量平衡方法成功量化了四环素化物中的各种杂质类.
- 含量被确定为自由基质量分数的重要因素.
- 分配的纯度:四环素自由形式 (898.80 ± 1.60) 毫克/克和盐形式 (972.65 ± 1.58) 毫克/克.
- 结果可以追溯到国际单位系统 (SI).
结论:
- 已经证明了一种新的,全面的程序来评估四环素化的纯度自由和盐的形式.
- 质量平衡方法为盐化合物的纯度确定提供了一个强大的框架.
- 这种方法提高了兽药分析和质量控制的可靠性.
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