澄清度检查法之仪器法的方法学研究

发布时间：2018-05-12 17:39

本文选题：澄清度检查法 + 仪器法　；参考：《中国药品标准》2016年04期

【摘要】：目的:建立澄清度检查法之仪器法。方法:参照《欧洲药典》溶液澄清度和浊度级别中的仪器法,采用三台国内外生产的浊度计进行方法学研究,对线性、稳定性和重复性进行考察,同时对有色溶液的澄清度检查是否适用于仪器法也进行考察。结果:散射光式浊度仪适用于对无色溶液进行浊度测定,线性、稳定性和重复性均符合要求;现有浊度计无法消除有色溶液中的颜色对浊度值测定的干扰。结论:现有散射光式浊度计适用于无色溶液的浊度值测定,对目视法无法有效判断的样品提供了补充检测方法。
[Abstract]:Objective: to establish an instrument method for clarification examination. Methods: referring to the instrumental method in the clarification and turbidity grade of the solution of the European Pharmacopoeia, three turbidimeters produced at home and abroad were used to study the methodology, and the linearity, stability and repeatability were investigated. At the same time, the clarity of the colored solution is also investigated. Results: the scattering-light turbidimeter is suitable for the turbidity measurement of colorless solution, the linearity, stability and repeatability are all in line with the requirement, and the existing turbidimeter can not eliminate the interference of the color in the colored solution to the determination of the turbidity value. Conclusion: the existing scattering turbidimeter is suitable for the determination of turbidity in colorless solution and provides a supplementary method for the determination of samples which cannot be effectively judged by visual method.
【作者单位】：北京市药品检验所;
【分类号】：R927.1

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