TOPICAL CORTICOSTEROIDS - QUALITY-CONTROL CONSIDERATIONS

被引：4

作者：

SHAH, VP

机构：

[1] Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland

来源：

INTERNATIONAL JOURNAL OF DERMATOLOGY | 1992年 / 31卷

关键词：

D O I：

10.1111/j.1365-4362.1992.tb04011.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

A simple procedure is developed, which can be used as a quality control test. The method utilizes commercially available diffusion cell assembly, synthetic membrane, and an appropriate receptor phase. The amount of drug released over time is determined using an HPLC method. From this, the drug release rate, flux, mug/cm2/min0.5 is calculated. This drug release rate can serve as a good quality control test to assure batch-to-batch uniformity.

引用

收藏

页码：34 / 37

页数：4

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