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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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帕博西尼的粒度激光散射测定方法的建立和验证

Establishment and verification of particle size test method of palbociclib by laser light scattering

作者(英文):
分类号:R917
出版年·卷·期(页码):2019,39 (3):436-440
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立激光散射法测定帕博西尼原料药的粒度分布。方法:采用Malvern Mastersizer 3000型激光粒度分析仪,干法测定模式,标准文丘里管,样品折射率1.52,样品吸收率0.01,遮光度0.5%~5.0%,背景和测定扫描时间5 s,气源压力0.15 MPa,进料速度40%,狭缝宽度1.5 mm,测定次数5次。结果:d(0.5)值的RSD均小于3%,d(0.1)和d(0.9)值的RSD均小于5%。结论:本法可用于测定帕博西尼原料药的粒度。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish a laser light scattering method for the determination of particle size distribution of palbociclib. Methods: A Malvern Mastersizer 3000 type laser size analyzer was used with a model of dry determination and standard venture tube. Determination conditions were selected as follows:sample refractive index of 1.52, sample absorbency of 0.01, shading degree of 0.5%-5.0%, measurement time for background and samples of 5 s,air press of 0.15 MPa,feed rate of 40%,slit width of 1.5 mm,measurement for 5 times. Results: The RSDs of methodological study for d (0.5) values were lower than 3%,and lower than 5% for both d (0.1) and d (0.9) values. Conclusion: The established method can be used for the detection of particle size distribution of palbociclib.

-----参考文献:---------------------------------------------------------------------------------------

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