An evaluation of a unit-dose compacting sample thief and a discussion of content uniformity testing and blending validation issues

被引：16

作者：

Chang, RK

Shukla, J

Buehler, J

机构：

[1] DuPont Merck Pharmaceutical Company, Experimental Station, Wilmington, DE 19880-0400

来源：

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY | 1996年 / 22卷 / 9-10期

关键词：

D O I：

10.3109/03639049609065937

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

The ability of the unit-dose compacting sample thief to provide quantitative, precise, and reproducible sampling of powder blends has been demonstrated in five cases. The thief enables the pharmaceutical researcher to comply with Food and Drug Administration guidelines for unit-dose sampling of powders and granulations. Some issues regarding blending validation and content uniformity testing have been addressed.

引用

页码：1031 / 1035

页数：5

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